Generated by Rank Math SEO, this is an llms.txt file designed to help LLMs better understand and index this website. # TruLaw ## Sitemaps [XML Sitemap](https://trulaw.com/sitemap_index.xml): Includes all crawlable and indexable pages. ## Posts - [Is the Fresenius Settlement Offer of $250 Million a Good Deal?](https://trulaw.com/is-the-fresenius-250-million-settlement-offer-a-good-deal/) - [What is a Deep Joint Infection (DJI)?](https://trulaw.com/what-is-a-deep-joint-infection-dji/) - [The Dangers of Vinyl Chloride, Phosgene, and Dioxins](https://trulaw.com/the-dangers-of-vinyl-chloride-phosgene-and-dioxins/) - [What Caused the Ohio Train Derailment and Chemical Spill in East, Palestine?](https://trulaw.com/what-caused-the-ohio-train-derailment-and-chemical-spill-in-east-palestine/) - [Research Finds Social Media Use Linked to Depression](https://trulaw.com/research-finds-social-media-use-linked-to-depression/) - [What Are the Symptoms of Necrotizing Enterocolitis?](https://trulaw.com/what-are-the-symptoms-of-necrotizing-enterocolitis/) - [Who Is Eligible for a Necrotizing Enterocolitis Lawsuit?](https://trulaw.com/who-is-eligible-for-a-necrotizing-enterocolitis-lawsuit/) - [Best Formula for Babies with Upset Stomach?](https://trulaw.com/best-formula-for-babies-with-upset-stomach/) - [Does Formula Upset Baby’s Stomach?](https://trulaw.com/does-formula-upset-babys-stomach/) - [What Is the Statute of Limitations for an NEC Baby Formula Lawsuit?](https://trulaw.com/what-is-the-statute-of-limitations-for-an-nec-baby-formula-lawsuit/) - [When Was Paraquat First Used?](https://trulaw.com/when-was-paraquat-first-used/) - [What Herbicides Contain Paraquat?](https://trulaw.com/what-herbicides-contain-paraquat/) - [What Is Paraquat Poisoning?](https://trulaw.com/what-is-paraquat-poisoning/) - [What Is Paraquat Exposure?](https://trulaw.com/what-is-paraquat-exposure/) - [Is Paraquat Banned in the U.S.?](https://trulaw.com/is-paraquat-banned-in-the-u-s/) - [Where Are PFAS Used?](https://trulaw.com/where-are-pfas-used/) - [Are PFAS Carcinogenic?](https://trulaw.com/are-pfas-carcinogenic/) - [Where Do PFAS Come From?](https://trulaw.com/where-do-pfas-come-from/) - [What Do PFAS Do to Your Body?](https://trulaw.com/what-do-pfas-do-to-your-body/) - [Can PFAS Be Absorbed through the Skin?](https://trulaw.com/can-pfas-be-absorbed-through-the-skin/) - [How Does NEC Cause Damage to the Intestine?](https://trulaw.com/how-does-nec-cause-damage-to-the-intestine/) - [How to Tell if Baby Formula Is Upsetting the Stomach](https://trulaw.com/how-to-tell-if-baby-formula-is-upsetting-the-stomach/) - [What Formulas Are in the NEC Lawsuit?](https://trulaw.com/what-formulas-are-in-the-nec-lawsuit/) - [What Is NEC in Newborns / Babies?](https://trulaw.com/what-is-nec-in-newborns-babies/) - [What Is NEC in Premature Babies?](https://trulaw.com/what-is-nec-in-premature-babies/) - [Where Are PFAS Found?](https://trulaw.com/where-are-pfas-found/) - [What Is/Are PFAS?](https://trulaw.com/what-is-are-pfas/) - [What Firefighting Foam Has PFAS?](https://trulaw.com/what-firefighting-foam-has-pfas/) - [Is Paraquat in Roundup?](https://trulaw.com/is-paraquat-in-roundup/) - [What Crops Is Paraquat Used On?](https://trulaw.com/what-crops-is-paraquat-used-on/) - [What Is Paraquat Used For?](https://trulaw.com/what-is-paraquat-used-for/) - [What Is Paraquat?](https://trulaw.com/what-is-paraquat/) - [What Products Contain Paraquat?](https://trulaw.com/what-products-contain-paraquat/) - [Are Firefighters’ Uniforms Toxic?](https://trulaw.com/are-firefighters-uniforms-toxic/) - [Firefighting Gear](https://trulaw.com/firefighting-gear/) - [Primary Focus of Drug Company Marketing: Profits, Not Patients](https://trulaw.com/drug-company-marketing-profits-not-patients/) - [St. Louis Jury Returns $4.69 Billion Verdict in Asbestos in Talc Lawsuit](https://trulaw.com/verdict-asbestos-talc-products/) - [Why Are There So Many Bad Drug Lawsuits?](https://trulaw.com/why-are-there-so-many-bad-drug-lawsuits/) - [St. Louis Asbestos-Related Talcum Powder Cases Move Forward](https://trulaw.com/stlouis-asbestos-talcum-powder-cases-move-forward/) - [Distracted Driving Awareness Month & Remembering Casey Feldman](https://trulaw.com/distracted-driving-awareness-remember-casey-feldman/) - [Immediate Ban of Benicar Demanded by Consumer Advocacy Group](https://trulaw.com/benicar-ban-by-consumer-advocacy-group/) - [6 Risky Stimulants That Put Your Health At Risk](https://trulaw.com/risky-stimulants/) - [Just Say No! 5 Reasons You Should Never Get An Essure Implant](https://trulaw.com/5-reasons-never-get-an-essure-implant/) - [Bayer Says Failed NAVIGATE Trial Won’t Affect Xarelto Sales Projections](https://trulaw.com/xarelto-navigate-trial-failure/) - [The 2018 ACA Health Insurance Marketplace Is Open Now  ](https://trulaw.com/2018-aca-health-insurance-marketplace-open-now/) - [Expert Urges National Review Of Mesh Implant Products That Put Patients At Risk](https://trulaw.com/expert-urges-national-review-mesh-implants/) - [Plaintiff Awarded $140M in AndroGel Verdict](https://trulaw.com/plaintiff-awarded-140m-testosterone-androgel-verdict/) - [Coffee Workers Exposed to Dangers of Diacetyl](https://trulaw.com/diacetyl-coffee-workers-exposed/) - [Aegerion Pharmaceuticals Fined $40M for Illegal Marketing of Juxtapid](https://trulaw.com/aegerion-juxtapid-illegal-marketing/) - [FDA Actions – The Life Cycle of a Bad Drug](https://trulaw.com/fda-actions-life-cycle-bad-drug/) - [FDA Warns Diabetics Taking Invokana – Amputation is a Risk!](https://trulaw.com/fda-warns-diabetics-taking-invokana-amputation-risk/) - [Benicar Lawsuit Settlement Reached](https://trulaw.com/benicar-lawsuit-settlement-reached/) - [Pradaxa and Xarelto Problems 2016 Highest Priority Drug Safety Problem](https://trulaw.com/pradaxa-xarelto-problems-2016-top-priority-drug-safety/) - [The Generic Drug Loophole – No Generic Drug Lawsuits](https://trulaw.com/generic-drug-loophole-no-generic-drug-lawsuits/) - [Xarelto Bleeding – The Trials Go On](https://trulaw.com/xarelto-bleeding-trials/) - [Canada Looking at Essure Class Action After Recall](https://trulaw.com/canada-looking-essure-class-action-recall/) - [H.R. 1215 – Limiting Your Day in Court](https://trulaw.com/hr-1215-limiting-your-day-in-court/) - [Depakote Birth Defect Case Results in $15 Million Verdict](https://trulaw.com/depakote-birth-defect-case-results-15-million-verdict/) - [Boehringer Ingelheim Sanctions Revisited in New Pradaxa Lawsuit](https://trulaw.com/new-pradaxa-lawsuit-sanctions/) - [FDA Granted Fast-Track Approval to Now Recalled Zimmer Shoulder Implants](https://trulaw.com/zimmer-shoulder-implants-fda-fast-track/) - [Virginia Widow Files Xarelto Law suit, Joining 18,000 Others](https://trulaw.com/virginia-widow-files-xarelto-law-suit/) - [FDA Issues Class 1 Recall of Zimmer Shoulder Replacement Device](https://trulaw.com/zimmer-shoulder-replacement/) - [Asbestos Bankruptcy and Asbestos Trust Fund Explained](https://trulaw.com/asbestos-bankruptcy-asbestos-trust-fund-explained/) - [Tennessee Valley Authority Found Negligent In Handling Asbestos Exposure](https://trulaw.com/teva-negligent-secondhand-asbestos-exposure/) - [Hylands Teething Tablet Lawsuit 2017 Filed Alleging Belladonna Side Effects](https://trulaw.com/hylands-teething-tablet-lawsuit-2017-side-effect-poison/) - [FDA Evaluates Rare Lymphoma Link To Breast Implants](https://trulaw.com/fda-evaluates-rare-lymphoma-link-to-breast-implants/) - [Abilify Compulsive Gambling Lawsuits Move Forward in Florida Federal Court](https://trulaw.com/abilify-compulsive-gambling-lawsuits-florida/) - [Asbestos Still Dangerous, But Remains in Use](https://trulaw.com/asbestos-dangerous-remains-used/) - [Tribune Reveals Pharmacists’ Failure to Warn of Dangerous Drug Combinations](https://trulaw.com/pharmacists-failure-dangerous-drug-combinations-warning/) - [How Breast Implants Could Increase the Risk of Cancer](https://trulaw.com/breast-implants-cancer-risk/) - [J&J Faces 18,500 Pending Risperdal Lawsuits](https://trulaw.com/jj-pending-risperdal-lawsuits/) - [FDA Receives Reports Linking Type 2 Diabetes Drug With Serious Skin Diseases](https://trulaw.com/fda-reports-diabetes-drugs-linked-skin-diseases/) - [Study Reviews Link Between Risperdal Dosage and Gynecomastia](https://trulaw.com/risperdal-dosage-gynecomastia-link/) - [Fluoroquinolone Side Effects Lead to Fluoroquinolone Lawsuits](https://trulaw.com/fluoroquinolone-side-effects-lawsuits/) - [Zimmer Recalls Reverse Shoulder Device Due to Injury](https://trulaw.com/zimmer-recalls-reverse-shoulder-device/) - [FDA: Type 2 Diabetes Drugs May Lead to Severe Joint Pain](https://trulaw.com/diabetes-drugs-joint-pain/) - [Could Synthetic Cannabinoids Help The Symptoms of Floxing?](https://trulaw.com/synthetic-cannabinoids-help-floxing/) - [Liver Injury Warning Added to Tecfidera Label](https://trulaw.com/tecfidera-liver-injury-warning/) - [Will Trump Presidency Spell Big Changes for the FDA?](https://trulaw.com/will-trump-presidency-change-fda/) - [Will The Trump Administration Turn Back Federal Vaping Laws?](https://trulaw.com/federal-vaping-laws/) - [Risperdal Lawsuit Settles Three Days Before Trial](https://trulaw.com/risperdal-lawsuit-settles/) - [DuPont C8 Chemical Dumping Case Gets Punitive Damages Added to Verdict](https://trulaw.com/dupont-c8-chemical-dumping-case/) - [It’s Not All in Your Head: Why Drug Side Effects Often Go Unnoticed](https://trulaw.com/drug-side-effects-unnoticed/) - [Thousands of Xarelto Lawsuit Currently Pending in U.S.](https://trulaw.com/xarelto-lawsuit-currently-pending-u-s/) - [Ovarian Cancer Support – A New Program for Women Battling Cancer](https://trulaw.com/ovarian-cancer-support-program-women-battling-cancer/) - [Study: Pelvic Mesh No More Effective than Standard Repair Technique](https://trulaw.com/study-pelvic-mesh/) - [AMA Applauds Surgeon General E-Cig Statement – Emerging Public Health Threat](https://trulaw.com/ecig-emerging-public-health-threat/) - [Xarelto Claims to be Heard in Coming Year Through Bellwether Trials](https://trulaw.com/xarelto-claims-heard-bellwether-trials/) - [Republican Lawmakers Want to Dump E-Cig Rules, Despite Health Risks to Teens](https://trulaw.com/e-cigs-rules/) - [E-Cigarettes Include Diacetyl And Is Not A Stop Smoking Aid, Says Experts](https://trulaw.com/e-cigs-stop-smoking-aid/) - [Lawsuits Question Xarelto Risk While FDA Assures Public of Xarelto Clinical Trial Data](https://trulaw.com/lawsuits-question-xarelto-risk/) - [Federal Jury Orders J&J to Pay $1.04 Billion in Hip Implant Lawsuit](https://trulaw.com/depuy-pinnacle-hip-settlement/) - [Cook Medical’s 2nd Bellwether Pick Approved In IVC Filter MDL](https://trulaw.com/bellwether-approved-ivc-filter-mdl/) - [Legal Loophole Keeping Essure Lawsuits From Being Filed](https://trulaw.com/essure-lawsuits-kept-from-being-filed/) - [Abilify and Gambling – Abilify Gambling Lawsuit Consolidated](https://trulaw.com/abilify-and-gambling-abilify-gambling-lawsuits/) - [Aortic Dissection Lawsuit Frequently Asked Questions](https://trulaw.com/aortic-dissection-lawsuit-frequently-asked-questions/) - [Study Examines Cancer Risk Associated With Morcellation](https://trulaw.com/morcellation-cancer-risk-study/) - [Janssen Outlines Plan to Overturn $70M Risperdal Verdict](https://trulaw.com/janssen-plan-overturn-70m-risperdal-verdict/) - [Abilify Law suit – Abilify Side Effects Gambling Result](https://trulaw.com/abilify-law-suit-abilify-side-effects-gambling/) - [FDA Rejects Proposed Xarelto Antidote](https://trulaw.com/fda-rejects-proposed-xarelto-antidote/) - [ISMP Links Invokana to Ketoacidosis](https://trulaw.com/invokana-ketoacidosis/) - [Medtronic SynchroMed II Litigation Moves Forward](https://trulaw.com/medtronic-synchromed-litigation-moves-forward/) - [California Environmental Group Files Petition to Regulate BPA](https://trulaw.com/regulate-bpa-petition/) - [What Draws Young People to E-Cigs?](https://trulaw.com/e-cigs/) - [First Cook IVC Filter Litigation Bellwether Trials to Begin Soon](https://trulaw.com/cook-ivc-filter-litigation/) - [Judge Selects Three Cook IVC Cases for Trial in 2017](https://trulaw.com/cook-ivc-cases/) - [Invokana Linked to Kidney Damage, Diabetic Ketoacidosis](https://trulaw.com/invokana-kidney-damage-diabetic-ketoacidosis/) - [Invokana Side Effects Subject of Lawsuits](https://trulaw.com/invokana-side-effects-lawsuits/) - [FDA Warns of Serious Injuries – Antibiotic Lawsuits Move Forward](https://trulaw.com/antibiotic-lawsuits-fda-warning/) - [JAMA: New Morcellation Device Does Not Eliminate Cancer Risk](https://trulaw.com/jama-new-morcellation-device-cancer-risk/) - [Invokana Diabetic Ketoacidosis Lawsuits Filed](https://trulaw.com/invokana-diabetic-ketoacidosis-lawsuits-filed/) - [FDA Approves New Power Morcellator Tissue Containment Device](https://trulaw.com/power-morcellator-lawsuits-move-forward-pneumoliner/) - [FDA Rules Extended to Cover Electronic Nicotine Delivery Systems](https://trulaw.com/fda-electronic-nicotine-delivery-systems/) - [Invokana Lawsuits Alleging Kidney Failure Filed](https://trulaw.com/invokana-lawsuit-kidney-failure/) - [Study: IVC Fracture “Relatively Common” When Placed Long Term](https://trulaw.com/ivc-filter-fracture-relatively-common/) - [Side Effects Xarelto – A History Told Through FDA Warnings](https://trulaw.com/side-effects-xarelto-history-told-through-fda-warnings/) - [Kentucky Risperdal Lawsuit Settles for $15.5 Million](https://trulaw.com/kentucky-risperdal-lawsuit-settles/) - [IVC Filter Lawsuits Spreading To Canada](https://trulaw.com/canada-ivc-filter-lawsuits/) - [Failure to Remove IVC Filters Contributing to Rise of IVC Thrombosis](https://trulaw.com/fail-to-remove-ivc-filters-contributing-rise-thrombosis/) - [How Do I Know If I Have Diacetyl Lung Damage?](https://trulaw.com/diacetyl-lung-damage/) - [IVC Filter Use May Be Rising, But Benefits Not So Much](https://trulaw.com/ivc-filter-use-may-rising-benefits-not-much/) - [Former Insys Sales Rep Pleads Guilty to Violating Kickback Laws](https://trulaw.com/former-insys-rep-pleads-guilty-violating-kickback-laws/) - [Janssen Loses Attempt to Overturn $124M Risperdal Verdict](https://trulaw.com/janssen-loses-overturn-risperdal-verdict/) - [Cook IVC Filter Cases Entering Discovery Pool](https://trulaw.com/cook-ivc-filter-cases-entering-discovery-pool/) - [Greenfield IVC Filter Device Failed, alleges plaintiff](https://trulaw.com/greenfield-ivc-filter-device-failed/) - [Study Reveals 43 Percent Perforation Risk with Cook IVC Filter](https://trulaw.com/43-percent-perforation-risk-with-cook-ivc-filter/) - [FDA Recommends Removal of Retrievable IVC Filters](https://trulaw.com/fda-recommends-ivc-filter-removal/) ## Pages - [About Us](https://trulaw.com/about-us/): TruLaw was founded to solve the problem of access to justice. - [Social Security Disability](https://trulaw.com/social-security-disability/) - [FDA Warnings & Information](https://trulaw.com/fda/) - [What Is A Bad Drug Lawsuit?](https://trulaw.com/bad-drug-lawsuit/) - [What Is A Defective Product Lawsuit?](https://trulaw.com/defective-product-lawsuit/) - [Class of Diabetes Drugs Linked to Painful Blistering Skin Condition](https://trulaw.com/blistering-skin-conditions/) - [Alabama Statute of Limitations](https://trulaw.com/sol-alabama/) - [How to Report Adverse Events to the FDA](https://trulaw.com/how-to-report-adverse-events-to-the-fda/) - [Legal Consultation](https://trulaw.com/legal-consultation/) - 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We encourage you to use the Instant Case Evaluator ℠ anytime. - [What is a Multidistrict Litigation (MDL)?](https://trulaw.com/multidistrict-litigation-mdl/) - [What is a Bellwether Trial?](https://trulaw.com/bellwether-trial/) - [Drug, Device and Toxic Contamination News, Alerts and Recalls](https://trulaw.com/news/) - [Home](https://trulaw.com/) ## Guides - [SSDI Hearing Loss: Does Hearing Loss Qualify for Disability?](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-hearing-loss-does-hearing-loss-qualify-for-disability-benefits/) - [SSDI Arthritis: Does Arthritis Qualify for Disability Benefits?](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-arthritis-does-arthritis-qualify-for-disability-benefits/) - [SSDI Depression: Does Depression Qualify for Disability Benefits?](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-depression-does-depression-qualify-for-disability-benefits/) - [SSDI Anxiety: Does Anxiety Qualify for Disability Benefits?](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-anxiety-does-anxiety-qualify-for-disability-benefits/) - [SSDI FAQ: How Do SSDI Lawsuits Impact Benefits Approval?](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-faq-how-do-ssdi-lawsuits-impact-benefits-approval/) - [SSDI Lawyers vs Self-Representation: When to Hire A Lawyer](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawyers-vs-self-representation-when-to-hire-a-lawyer/) - [SSDI Lawsuit: How SSDI Lawyers Ensure Fair Benefits](https://trulaw.com/legal-guides/social-security-disability-insurance/how-ssdi-lawyers-ensure-fair-benefits-in-ssdi-lawsuits/) - [What Is The Difference Between SSDI and SSI?](https://trulaw.com/legal-guides/social-security-disability-insurance/what-is-the-difference-between-ssdi-and-ssi/) - [When Can You File An SSDI Lawsuit After A Denial?](https://trulaw.com/legal-guides/social-security-disability-insurance/when-can-you-file-an-ssdi-lawsuit-after-a-denial/) - [When Should You Consider Hiring An SSDI Lawyer?](https://trulaw.com/legal-guides/social-security-disability-insurance/when-should-you-consider-hiring-an-ssdi-lawyer/) - [Why Do Some SSDI Applications Get Denied?](https://trulaw.com/legal-guides/social-security-disability-insurance/why-do-some-ssdi-applications-get-denied/) - [How to Win Social Security Disability Insurance Benefits For Trauma Disorders?](https://trulaw.com/legal-guides/social-security-disability-insurance/how-to-win-social-security-disability-insurance-benefits-for-trauma-disorders/) - [Winning a SSDI Lawsuit: What Happens Next?](https://trulaw.com/legal-guides/social-security-disability-insurance/what-happens-after-winning-an-ssdi-lawsuit/) - [SSDI Lawsuits and Mental Health Disabilities: What to Know](https://trulaw.com/legal-guides/social-security-disability-insurance/what-to-know-about-ssdi-lawsuits-and-mental-health-disabilities/) - [SSDI Lawsuits: Your Comprehensive Guide to Navigating the Process](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuits-your-comprehensive-guide-to-navigating-the-process/) - [SSDI Lawsuits & Long-Term Disability: Ensuring Financial Security](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuits-and-long-term-disability-ensuring-financial-security/) - [SSDI Lawsuits: Essential Guide to Legal Representation](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuits-essential-guide-to-legal-representation/) - [SSDI Lawsuits: Your Guide to Choosing the Perfect Legal Representation](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuits-your-guide-to-choosing-the-perfect-legal-representation/) - [SSDI Lawsuits Uncovered: Class Actions Tackling Systemic Issues](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuits-uncovered-class-actions-tackling-systemic-issues/) - [SSDI Lawsuit: Decoding Denials and Knowing When to File](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuit-decoding-denials-and-knowing-when-to-file/) - [SSDI Lawsuit: Impact of Personal Injury Settlement](https://trulaw.com/legal-guides/social-security-disability-insurance/ssdi-lawsuit-impact-of-personal-injury-settlement/) - [Social Security Disability Lawsuit: A Complete Comprehensive Guide](https://trulaw.com/legal-guides/social-security-disability-insurance/social-security-disability-lawsuit-a-complete-comprehensive-guide/):     - [FAQ: What is the Social Security Disability 5 Year Rule?](https://trulaw.com/legal-guides/social-security-disability-insurance/what-is-the-social-security-disability-5-year-rule/):     - [Social Security Disability Insurance: The Ultimate Guide](https://trulaw.com/legal-guides/social-security-disability-insurance/):       ## Practice Areas - [Internal Bra Complications: Signs, Symptoms & What to Do](https://trulaw.com/breast-mesh-lawsuits/internal-bra-complications/) - [Nevro Spinal Cord Stimulator Lawsuit](https://trulaw.com/spinal-cord-stimulator-lawsuit/nevro-spinal-cord-stimulator-lawsuit/) - [Caesars Sportsbook Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/caesars-sportsbook-lawsuit-for-gambling-addiction/) - [GalaFlex Mesh Lawsuit](https://trulaw.com/breast-mesh-lawsuits/galaflex-mesh-lawsuit/) - [Breast Mesh Lawsuits](https://trulaw.com/breast-mesh-lawsuits/) - [Fanatics Sportsbook Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/fanatics-sportsbook-lawsuit-for-gambling-addiction/) - [Medtronic Spinal Cord Stimulator Lawsuit](https://trulaw.com/spinal-cord-stimulator-lawsuit/medtronic-spinal-cord-stimulator-lawsuit/) - [Do I Qualify for a Gambling Addiction Lawsuit?](https://trulaw.com/online-gambling-addiction-lawsuit/do-i-qualify-for-a-gambling-addiction-lawsuit/) - [Gambling Addiction Lawsuit Settlement Amounts](https://trulaw.com/online-gambling-addiction-lawsuit/gambling-addiction-lawsuit-settlement-amounts/) - [Bet365 Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/bet365-lawsuit-for-gambling-addiction/) - [Sterigenics Atlanta Cancer Map](https://trulaw.com/ethylene-oxide-lawsuit/sterigenics-lawsuit-atlanta/sterigenics-atlanta-cancer-map/) - [Ozempic Blindness Lawsuit](https://trulaw.com/ozempic-lawsuit/ozempic-blindness-lawsuit/) - [Sports Betting Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/sports-betting-lawsuit-for-gambling-addiction/) - [Boston Scientific Spinal Cord Stimulator Problems Lawsuit](https://trulaw.com/spinal-cord-stimulator-lawsuit/boston-scientific-spinal-cord-stimulator-problems-lawsuit/) - [FanDuel Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/fanduel-lawsuit-for-gambling-addiction/) - [BetMGM Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/betmgm-lawsuit-for-gambling-addiction/) - [How to Hire A Gambling Lawyer for Gambling Addiction Claims](https://trulaw.com/online-gambling-addiction-lawsuit/how-to-hire-a-gambling-lawyer-for-gambling-addiction-claims/) - [DraftKings Lawsuit for Gambling Addiction](https://trulaw.com/online-gambling-addiction-lawsuit/draftkings-lawsuit-for-gambling-addiction/) - [Character.ai Lawsuit](https://trulaw.com/ai-suicide-lawsuit/character-ai-lawsuit/) - [Dupixent Lawsuit for T-Cell Lymphoma Claims](https://trulaw.com/dupixent-lawsuit/) - [Who Qualifies to File a Roblox Child Predator Lawsuit Claim?](https://trulaw.com/roblox-lawsuit/who-qualifies-to-file-a-roblox-child-predator-lawsuit-claim/) - [AI Suicide Lawsuit](https://trulaw.com/ai-suicide-lawsuit/) - [Online Gambling Addiction Lawsuit](https://trulaw.com/online-gambling-addiction-lawsuit/) - 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According to the FDA, internal testing confirmed the presence of undeclared almonds in the affected product. - [FDA Warns – Natural Dior LLC recalls Vitafer-L Gold Liquid supplement, claiming undeclared tadalafil](https://trulaw.com/fda/fda-warns-natural-dior-llc-recalls-vitafer-l-gold-liquid-supplement-claiming-undeclared-tadalafil/): The American company Natural Dior LLC is recalling ten lots of their Vitafer-L Gold Liquid vitamin supplement after testing detected the presence of tadalafil in the product. According to the FDA, Natural Dior announced the recall on February 25th. - [FDA Warns – CAPS recalls Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags after supplier finds black particulate](https://trulaw.com/fda/fda-warns-caps-recalls-phenylephrine-40-mg-added-to-0-9-sodium-chloride-250-ml-in-250-ml-excel-bags-after-supplier-finds-black-particulate/): Detection of foreign particulate has prompted Central Admixture Pharmacy (CAPS) to recall three lots of their Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags. According to the FDA, the company notified hospitals and distributors of the recall on Monday. - [FDA Warns – Bacterial contamination prompts Ascent Consumer Products Inc. to recall SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System](https://trulaw.com/fda/fda-warns-bacterial-contamination-prompts-ascent-consumer-products-inc-to-recall-sinucleanse-soft-tip-squeeze-bottle-nasal-wash-system/): On Tuesday, Ascent Consumer Products Inc. of New York issued a recall of their SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System. The FDA attributes the recall to possible product contamination with the bacteria Staphylococcos aureus. - [FDA Warns – Ongoing Listeria outbreak prompts recall of Lyons Magnus ReadyCare and Sysco Imperial nutritional shakes](https://trulaw.com/fda/fda-warns-ongoing-listeria-outbreak-prompts-recall-of-lyons-magnus-readycare-and-sysco-imperial-nutritional-shakes/): In conjunction with the FDA, Lyons Magnus of California is recalling several flavors of their supplemental shakes in response to an ongoing outbreak of Listeria monocytogenes. The announcement follows the lead of an earlier recall initiated by the manufacturer of the shakes, Prairie Farms Dairy of Indiana. - [FDA Warns – Packaging error, undeclared milk cause recall of Glicks Dark Chocolate Conettos](https://trulaw.com/fda/fda-warns-packaging-error-undeclared-milk-cause-recall-of-glicks-dark-chocolate-conettos/): The food manufacturing company Kayco of New Jersey is recalling one lot of their Glicks Dark Chocolate Conettos due to safety concerns regarding undeclared milk in the product. According to the FDA, the company announced the recall on Friday. - [FDA Warns – Naturipe Value Added Fresh LLC recalls Berry Buddies, Berries and Pancakes snack packs, citing undeclared milk and wheat](https://trulaw.com/fda/fda-warns-naturipe-value-added-fresh-llc-recalls-berry-buddies-berries-and-pancakes-snack-packs-citing-undeclared-milk-and-wheat/): A labeling error has prompted Naturipe Value Added Fresh LLC to recall one lot of their Berry Buddies, Berries & Pancakes snack packs. According to the FDA, the labeling error resulted in undeclared milk and wheat ingredients. - [FDA Warns – BD initiates recall of ChloraPrep™ Clear 1 mL Applicators due to risk of fungal contamination](https://trulaw.com/fda/fda-warns-bd-initiates-recall-of-chloraprep-clear-1-ml-applicators-due-to-risk-of-fungal-contamination/): The medical device company BD out of New Jersey issued a recall over the weekend of one lot of their ChloraPrep™ Clear 1 mL Applicators. According to the FDA, the potential for fungal contamination prompted the recall. - [FDA alerts to updated use instructions for Impella RP with SmartAssist, Impella RP Flex with SmartAssist by Abiomed, Inc.](https://trulaw.com/fda/fda-alerts-to-updated-use-instructions-for-impella-rp-with-smartassist-impella-rp-flex-with-smartassist-by-abiomed-inc/): The FDA is advising all users and medical professionals of important updates involving the December 12, 2024 recall of Abiomed, Inc.'s Impella RP with SmartAssist and Impella RP Flex with SmartAssist. - [FDA Warns – JE Bakery 2019 recalls 6-Count Raisin Brain Muffins, citing labelling error, undeclared tree nuts](https://trulaw.com/fda/fda-warns-je-bakery-2019-recalls-6-count-raisin-brain-muffins-citing-labelling-error-undeclared-tree-nuts/): On Thursday, JE Bakery 2019 out of Minnesota issued a recall of their 6-Count Raisin Bran Muffins due to a labelling error. According to the FDA, the recalled product contains undeclared walnuts, which is a known allergen. - [FDA Warns – Wrong dosage marked on lot of 20 mEq ICU Medical Potassium Chloride Injection bags, prompting recall](https://trulaw.com/fda/fda-warns-wrong-dosage-marked-on-lot-of-20-meq-icu-medical-potassium-chloride-injection-bags-prompting-recall/): ICU Medical, Inc. of Illinois has issued an urgent recall of one lot of their Potassium Chloride Injection bags due to a labelling error. As reported by the FDA, use of the recalled product could result in patients receiving a dangerous overdose of potassium chloride. - [FDA Warns – Jiangsu Jumao X-Care Medical Equipment recalls TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) after reports of fire, melting](https://trulaw.com/fda/fda-warns-jiangsu-jumao-x-care-medical-equipment-recalls-truaire-5-o2-concentrator-model-o2c5l-after-reports-of-fire-melting/): In late November, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. issued a Class I recall pertaining to several units of their TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L). According to the FDA, the device is at risk of melting and catching fire, posing a safety issues for patients. - [FDA Warns – Concern over possible Listeria contamination prompts recall of Jack and the Green Sprouts Alfalfa Sprouts](https://trulaw.com/fda/fda-warns-concern-over-possible-listeria-contamination-prompts-recall-of-jack-and-the-green-sprouts-alfalfa-sprouts/): Last Friday, Jack and the Green Sprouts, Inc. of Wisconsin recalled one lot of their 5-ounce packaged Alfalfa sprouts. The FDA attributes the recall to concerns over possible Listeria monocytogenes contamination. - [FDA Warns – Citing safety risks, Medline Industries, LP, issues Class I recall of their Integrated Arterial Catheters](https://trulaw.com/fda/fda-warns-citing-safety-risks-medline-industries-lp-issues-class-i-recall-of-their-integrated-arterial-catheters/): Late last year, Medline Industries, LP, announced a class I recall of multiple lots of kits, trays, and bundles containing their Integrated Arterial Catheters. According to the FDA, a manufacturing defect on the hubs of the catheters presents a serious safety risk for patients. - [FDA Warns – Tri-Union Seafoods reports manufacturing defect, recalls multiple lots of canned tuna products](https://trulaw.com/fda/fda-warns-tri-union-seafoods-reports-manufacturing-defect-recalls-multiple-lots-of-canned-tuna-products/): Late last week, Tri-Union Seafoods out of California recalled 34 lots of canned tuna products sold under four different brand names. The FDA attributes the recall to the health hazards associated with possible contamination with Clostridium botulinum. - [FDA Warns – Blue Ridge Beef recalls 1 lot of Natural Mix dog food logs after samples test positive for Salmonella](https://trulaw.com/fda/fda-warns-blue-ridge-beef-recalls-1-lot-of-natural-mix-dog-food-logs-after-samples-test-positive-for-salmonella/): Late last week, Blue Ridge Beef out of North Carolina announced a recall of one lot, or 5,700 lbs., of their 2-pound Natural Mix logs for dogs. According to the FDA, samples from the recalled lot tested positive for contamination with Salmonella. - [FDA Warns – Turkana Food Inc. recalls 1 lot of Aleppo Tahini Sesame Paste after positive test for bacterial contaminant](https://trulaw.com/fda/fda-warns-turkana-food-inc-recalls-1-lot-of-aleppo-tahini-sesame-paste-after-positive-test-for-bacterial-contaminant/): According to the FDA, concerns about possible Salmonella contamination have prompted Turkana Food Inc. out of New Jersey to recall one lot of their Aleppo Tahini Sesame Paste. The company announced the recall on Thursday. - [FDA Warns – Baxter Healthcare discovers malfunction with battery charger, issues urgent correction for their Life2000 Ventilators](https://trulaw.com/fda/fda-warns-baxter-healthcare-discovers-malfunction-with-battery-charger-issues-urgent-correction-for-their-life2000-ventilators/): Near the end of December, Baxter Healthcare Corporation issued an urgent correction for four models of their Life2000 Ventilator. According to the FDA, the correction pertains to a malfunction with the battery charger for the device. - [FDA Warns – United Natural Trading LLC cites labelling issue, undeclared milk in recall of Fresh Direct Dark Chocolate Covered Pretzels](https://trulaw.com/fda/fda-warns-united-natural-trading-llc-cites-labelling-issue-undeclared-milk-in-recall-of-fresh-direct-dark-chocolate-covered-pretzels/): According to the FDA, United Natural Trading LLC out of New Jersey is recalling one lot of their Fresh Direct Dark Chocolate Covered Pretzels. The company cites undeclared milk as the reason for the recall. - [FDA Warns – GERBER® SOOTHE N CHEW® TEETHING STICKS recalled, discontinued due to choking hazard](https://trulaw.com/fda/fda-warns-gerber-soothe-n-chew-teething-sticks-recalled-discontinued-due-to-choking-hazard/): Late last week, Gerber Products Company out of Virginia announced the recall and discontinuation of their GERBER® SOOTHE N CHEW® TEETHING STICKS. According to the FDA, concerns about choking prompted the recall. - [FDA Warns – Serious safety issue prompts recall of 1 lot of Alvogen’s Fentanyl Transdermal System 25 mcg/h patches](https://trulaw.com/fda/fda-warns-serious-safety-issue-prompts-recall-of-1-lot-of-alvogens-fentanyl-transdermal-system-25-mcg-h-patches/): According to the FDA, Alvogen, Inc. is recalling one lot of their Fentanyl Transdermal System 25 mcg/h transdermal patches due to a potentially dangerous packaging issue. The company announced the recall on Friday, January 31st. - [FDA Warns – Olympus Corporation advises re: risk of injury, infection with continued use of their Forceps/Irrigation Plug model MAJ-891](https://trulaw.com/fda/fda-warns-olympus-corporation-advises-re-risk-of-injury-infection-with-continued-use-of-their-forceps-irrigation-plug-model-maj-891/): The Olympus Corporation out of Pennsylvania issued an Advisory Notice just over a month ago notifying health care professionals of the potential risks associated with continued use of their re-usable Forceps/Irrigation Plug (Isolated Type) model MAJ-891. The FDA published the announcement on Thursday, January 29th. - [FDA Warns – Packaging error results in undeclared sesame, leading La Fiesta Food Products to recall Pan Rayado bread crumbs](https://trulaw.com/fda/fda-warns-packaging-error-results-in-undeclared-sesame-leading-la-fiesta-food-products-to-recall-pan-rayado-bread-crumbs/): On Saturday, the discovery of an undeclared allergen prompted La Fiesta Food Products, LLC to recall five lots total of their La Fiesta Pan Rayado Bread Crumbs and two lots of their Pan Rayado Sazonado Bread Crumbs. The FDA published notice of the recall on Tuesday. - [FDA Warns – Supplier substitution results in undeclared soy, prompting TS Food Packaging to recall popcorn seasonings](https://trulaw.com/fda/fda-warns-supplier-substitution-results-in-undeclared-soy-prompting-ts-food-packaging-to-recall-popcorn-seasonings/): Last Friday, TS Food Packaging out of Wisconsin announced a recall of 11 lots total of their Rural King Bacon Flavor Popcorn Seasoning and their Wasbash Valley Farms Bacon Flavor Popcorn Seasoning. The FDA attributes the recall to undeclared soy in the product. - [FDA Warns – New York Wholesale Group recalls Zaarah Herbals Shatavari Powder after testing finds elevated lead levels](https://trulaw.com/fda/fda-warns-new-york-wholesale-group-recalls-zaarah-herbals-shatavari-powder-after-testing-finds-elevated-lead-levels/): New York Wholesale Group out of Hicksville has announced a recall of their Zaarah Herbals Shatavari Powder after testing detected potentially dangerous levels of lead in the product. According to the FDA, the company initiated the recall on Monday. - [FDA Warns – Provepharm Inc. recalls 1 lot of Phenylephrine hydrochloride Injection (USP, 10 mg/ mL) after black particulate found in vial](https://trulaw.com/fda/fda-warns-provepharm-inc-recalls-1-lot-of-phenylephrine-hydrochloride-injection-usp-10-mg-ml-after-black-particulate-found-in-vial/): According to the FDA, the pharmaceutical company Provepharm Inc. out of Pennsylvania is recalling one lot of their Phenylephrine hydrochloride Injection (USP, 10 mg/ mL).  The company says the pre-filled vials may be contaminated with an unknown particulate. - [FDA Warns – Inspectors find undeclared sulfites in Apna Wholesale’s Paras Premium Golden Raisins, prompting recall](https://trulaw.com/fda/fda-warns-inspectors-find-undeclared-sulfites-in-apna-wholesales-paras-premium-golden-raisins-prompting-recall/): According to the FDA, Apna Wholesale Inc. initiated a recall earlier this month of their Paras Premium Golden Raisins. The company referenced undeclared sulfites as the reason for the recall. - [FDA Alerts – FDA warns of potential anaphylactic reaction in patients treated with glatiramer acetate (Copaxone, Glatopa)](https://trulaw.com/fda/fda-alerts-fda-warns-of-potential-anaphylactic-reaction-in-patients-treated-with-glatiramer-acetate-copaxone-glatopa/): On Wednesday, the FDA advised patients and health care providers that they would be adding a Boxed Warning to the medication glatiramer acetate, which is marketed as Copaxone or Glatopa. Patients undergoing treatment with glatiramer acetate, says the FDA, are at increased risk for anaphylaxis. - [FDA warns – Wisemettac Asian Foods, Inc. discovers undeclared milk, recalls all lots of their Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor](https://trulaw.com/fda/fda-warns-wisemettac-asian-foods-inc-discovers-undeclared-milk-recalls-all-lots-of-their-shirakiku-brand-curvee-puffs-corn-puff-snack-curry-flavor/): This past Friday, Wisemettac Asian Foods, Inc. issued a recall for all lots of their 2.46-ounce Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor. According to the FDA, the company cited undeclared milk as the reason for the recall. - [FDA Warns – Monkey Spit LLC barbeque sauce recall prompted by FDA discovery of undeclared wheat, soy, and milk](https://trulaw.com/fda/fda-warns-monkey-spit-llc-barbeque-sauce-recall-prompted-by-fda-discovery-of-undeclared-what-soy-and-milk/): Monkey Spit, LLC out of California is recalling three varieties of their barbecue sauces after an FDA investigation identified three undeclared allergens in the products. The FDA announced the recall last Friday, January 17th. - [FDA Warns – Citing serious injuries, MaxMobility/Permobil recalls SmartDrive Speed Control Dials used with their SmartDrive MX2+ Power Assist Devices](https://trulaw.com/fda/fda-warns-citing-serious-injuries-maxmobility-permobil-recalls-smartdrive-speed-control-dials-used-with-their-smartdrive-mx2-power-assist-devices/): Late last month, Max Mobility/Permobil announced a nationwide recall of the SmartDrive Speed Control Dial used with their SmartDrive MX2+ Power Assist Device. As explained by the FDA, the recall applies only to the Speed Control Dial and not to the company's automated wheelchair devices. - [FDA Warns – Potential for undeclared milk prompts recall of Pearl Milling Company Original Pancake & Waffle Mix](https://trulaw.com/fda/fda-warns-potential-for-undeclared-milk-prompts-recall-of-pearl-milling-company-original-pancake-waffle-mix/): The Quaker Oats Company out of Illinois has announced a recall of one of lot of their two-pound Pearl Milling Company Original Pancake & Waffle Mix. According to the FDA, the company initiated the recall after discovering undeclared milk in the product. - [FDA Warns – Packaging error results in undeclared egg, leads to recall of 2 lots of My Mochi Peach Mango Sorbet](https://trulaw.com/fda/fda-warns-packaging-error-results-in-undeclared-egg-leads-to-recall-of-2-lots-of-my-mochi-peach-mango-sorbet/): A temporary packaging error prompted My Mochi Ice Cream Company LLC to recall two lots of their Peach Mango Sorbet last week. According to the FDA, the impacted product may contain undeclared egg white, presenting a danger for people with egg allergies and sensitivities. - [FDA warns – Safety issue caused by inverted slide clamps prompts recall of Baxter Healthcare’s Solution Sets with Duo-Vent Spikes](https://trulaw.com/fda/fda-warns-safety-issue-caused-by-inverted-slide-clamps-prompts-recall-of-baxter-healthcares-solution-sets-with-duo-vent-spikes/): An assembly error prompted Baxter Healthcare to issue a recall late last month of four lots of their Solution Sets with Duo-Vent Spikes. According to the FDA, continued use of the impacted solution sets could cause injury to patients undergoing infusion. - [FDA Warns – Lifestyle Evolution Inc. joins retailers in recall of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars due to undeclared milk](https://trulaw.com/fda/fda-warns-lifestyle-evolution-inc-joins-retailers-in-recall-of-nugo-dark-chocolate-chip-and-dark-chocolate-pretzel-nutrition-bars-due-to-undeclared-milk/): On Friday, Lifestyle Evolution Inc. voluntarily recalled several lots of their NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars after testing confirmed undeclared milk ingredients in the product. According to the FDA, several retailers initiated a recall of these same products a month prior. - [FDA Warns – Testing confirms probable Salmonella contamination, prompts recall of 1 lot of Blue Ridge Beef’s 2-pound Kitten Mix logs](https://trulaw.com/fda/fda-warns-testing-confirms-probable-salmonella-contamination-prompts-recall-of-1-lot-of-blue-ridge-beefs-2-pound-kitten-mix-logs/): Shortly after the new year, Blue Ridge Beef out of North Carolina announced a recall of 675 logs of their 2-pound Kitten Mix. According to the FDA, the product tested positive for Salmonella contamination. - [FDA Warns – Undeclared milk ingredients prompt recall of Lidl US’s Taste of Deutschland Buttered Vegetables](https://trulaw.com/fda/fda-warns-undeclared-milk-ingredients-prompt-recall-of-lidl-uss-taste-of-deutschland-buttered-vegetables/): Late last month, the American grocery chain Lidl US recalled all lots of their Taste of Deutschland Buttered Vegetables after finding that milk had been omitted from the ingredient list. The FDA published notice of the recall on December 20, 2024. - [FDA Warns – Dierbergs Markets recalls 16oz Premium Home-Style Mashed Potatoes due to undeclared wheat](https://trulaw.com/fda/fda-warns-dierbergs-markets-recalls-16oz-premium-home-style-mashed-potatoes-due-to-undeclared-wheat/): Dierbergs Markets out of Missouri issued a recall on Friday for one lot of their 16oz Premium Home-Style Mashed Potatoes. As explained by the FDA, the company found that the specified lot contains undeclared wheat, which poses a risk for people with Celiac disease and wheat or gluten allergies. - [FDA Warns – Nuwellis identifies safety issues, urges providers to remove 24 lots of AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit from use](https://trulaw.com/fda/fda-warns-nuwellis-identifies-safety-issues-urges-providers-to-remove-24-lots-of-aquaflexflow-uf-500-plus-extracorporeal-blood-circuit-from-use/): The FDA issued an early alert last Monday regarding potential safety issues identified with the AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit produced and distributed by Nuwellis. The FDA's alert followed a safety warning sent by Nuwellis to health care providers. - [FDA Warns – Packaging error results in undeclared cashews, prompting recall of Gardners Candies’ Cappucino Meltaway® Bars](https://trulaw.com/fda/fda-warns-packaging-error-results-in-undeclared-cashews-prompting-recall-of-gardners-candies-cappucino-meltaway-bars/): Shortly after Christmas, Gardners Candies out of Pennsylvania issued a recall for three lots of candies containing their Cappuccino Meltaway® Bars. According to the FDA, a packaging issue caused the omission of cashews from the product's ingredient list. - [FDA Warns – Inspection detects undeclared Yellow 5 and Yellow 6 in Jose Madrid Salsa’s Chipotle Con Queso Salsa, recall ensues](https://trulaw.com/fda/fda-warns-inspection-detects-undeclared-yellow-5-and-yellow-6-in-jose-madrid-salsas-chipotle-con-queso-salsa-recall-ensues/): Two weeks ago, Jose Madrid Salsa announced a recall of three lots of its Chipotle Con Queso Salsa after an inspection detected Yellow 5 and Yellow 6 in the product. The FDA published notice of the company's recall on Friday, December 20th. - [FDA Warns – Empty capsules found in ROPGRAF® 0.5mg and ASTAGRAF XL® 0.5mg, 1 lot of each recalled](https://trulaw.com/fda/fda-warns-empty-capsules-found-in-ropgraf-0-5mg-and-astagraf-xl-0-5mg-1-lot-of-each-recalled/): The FDA recently posted a recall announcement released by Astellas Pharma US regarding an urgent recall of one lot each of their PROGRAF and ASTAGRAF XL medications. Astellas Pharma says the recalled lots may contain empty capsules and could post a significant risk to transplant patients. - [FDA Warns – Possible peanut contamination prompts recall of 1 lot of Orgain’s 2.01 lb. chocolate plant-based protein powder](https://trulaw.com/fda/fda-warns-possible-peanut-contamination-prompts-recall-of-1-lot-of-orgains-2-01-lb-chocolate-plant-based-protein-powder/): The nutritional supplement Orgain out of California issued a recall earlier this month for one lot of its 30g Protein Organic Plant Based Powder - Chocolate 2.01lb. According to the announcement posted on the FDA's website, Orgain announced the recall due to concerns regarding possible peanut allergens in the product. - [FDA Warns – Alcon Laboratories recalls 1 lot of Systane Lubricant Eye Drops Ultra PF after identifying fungal contaminant](https://trulaw.com/fda/fda-warns-alcon-laboratories-recalls-1-lot-of-systane-lubricant-eye-drops-ultra-pf-after-identifying-fungal-contaminant/): The Swiss-American pharmaceutical company Alcon Laboratories is recalling one lot of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go. According to the FDA, the company issued the recall after identifying a fungal contaminant in the product. - [FDA Warns – Citing possible contamination, Palermo Villa, Inc. recalls 1 lot of Connie’s Thin Crust Cheese frozen pizzas](https://trulaw.com/fda/fda-warns-citing-possible-contamination-palermo-villa-inc-recalls-1-lot-of-connies-thin-crust-cheese-frozen-pizzas/): Palermo Villa, Inc. of Milwaukee issued a recall last week of one lot of Connie’s Thin Crust Cheese frozen pizzas. According to the FDA, the company has reason to believe that the recalled pizzas may have been contaminated with plastic or metal. - [FDA Warns – Shoppers-Plaza recalls Fouzee SugarLin Herbal Formula due to undisclosed metformin and glyburide](https://trulaw.com/fda/fda-warns-shoppers-plaza-recalls-fouzee-sugarlin-herbal-formula-due-to-undisclosed-metformin-and-glyburide/): The health and beauty company Shoppers-Plaza of California announced a recall of all lots of their Fouzee SugarLin Herbal Formula. According to the announcement published this week by the FDA, the product contains undeclared pharmaceutical drugs. - [FDA Warns – Frito-Lay recalls select 13 oz. bags of Classic Potato Chips after finding undeclared milk in the product](https://trulaw.com/fda/fda-warns-frito-lay-recalls-select-13-oz-bags-of-classic-potato-chips-after-finding-undeclared-milk-in-the-product/): Frito-Lay is recalling at least one lot of their 13-ounce bags of Lay’s Classic Potato Chips after receiving reports of undeclared milk in the product. According to the FDA, the company announced the recall on Monday, December 16th. - [FDA Warns – Reser’s Fine Foods recalls Sprouts’ Gyro Family Kits containing cucumbers at risk for Salmonella contamination](https://trulaw.com/fda/fda-warns-resers-fine-foods-recalls-sprouts-gyro-family-kits-containing-cucumbers-at-risk-for-salmonella-contamination/): In conjunction with a larger nationwide recall of cucumbers, Reser's Fine Food has issued a recall for their Sprouts Farmers Market Gyro Family Kits. According to the FDA, the company issued the recall on Monday, December 9th. - [FDA Warns – Drug Safety Communication notifies health care providers of increased risk of liver injury in patients taking Ocaliva](https://trulaw.com/fda/fda-warns-drug-safety-communication-notifies-health-care-providers-of-increased-risk-of-liver-injury-in-patients-taking-ocaliva/): Last Thursday, the FDA issued a Drug Safety Communication to health care professionals and pharmacists regarding a potentially serious safety issue with the drug Ocaliva (obeticholic acid). The safety notice includes specific guidelines for prescribing the drug and monitoring safety in patients taking the drug. - [FDA Warns – Motivate Me Ashley LLC recalls VidaSlim supplements after FDA testing detects toxic yellow oleander](https://trulaw.com/fda/fda-warns-motivate-me-ashley-llc-recalls-vidaslim-supplements-after-fda-testing-detects-toxic-yellow-oleander/): After FDA testing detected yellow oleander in their supplement line, Motivate Me Ashley, LLC, of San Antonio recalled multiple varieties of their VidaSlim product. According to the FDA, the company announced the recall on December 13, 2024. - [FDA Warns – MadeGood alerts public to risk of metal in granola bars, recalls multiple varieties and lots](https://trulaw.com/fda/fda-warns-madegood-alerts-public-to-risk-of-metal-in-granola-bars-recalls-multiple-varieties-and-lots/): Riverside Natural Foods of Canada announced an international recall of multiple lots and varieties of their MadeGood granola bars on Monday. According to the FDA, a manufacturing issue may have resulted in metal contamination in the products. - [FDA Warns – Product defect prompts Cardinal Health to remove 3 lots of Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs](https://trulaw.com/fda/fda-warns-product-defect-prompts-cardinal-health-to-remove-3-lots-of-monoject-u-100-ml-insulin-syringe-luer-lock-with-tip-cap-soft-packs/): According to the FDA, Cardinal Health has issued a recall of their Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs after determining that they do not fit correctly with needleless IV connectors. The company sent the recall letter on September 25, 2024. - [FDA Warns – Borsari Food Co. recalls Bloody Mary Mix that contains both undeclared fish and soy](https://trulaw.com/fda/fda-warns-borsari-food-co-recalls-bloody-mary-mix-that-contains-both-undeclared-fish-and-soy/): On Monday, Borsari Food Company announced a recall of its Bloody Mary Mix after state officials notified the company of undeclared allergens in the product. According to the FDA, the product contains both fish and soy, neither of which are listed on the label. - [FDA Warns – Dairyland Produce recalls 7 lots of cucumbers sourced from SunFed Produce due to possible Salmonella contamination](https://trulaw.com/fda/fda-warns-dairyland-produce-recalls-7-lots-of-cucumbers-sourced-from-sunfed-produce-due-to-possible-salmonella-contamination/): Dairyland Produce, LLC, more commonly known as Hardie's Fresh Foods, is recalling seven lots of whole cucumbers that were sourced from a grower implicated in a nationwide Salmonella outbreak. According to the FDA, Hardie's issued the recall on Thursday, December 5th. - [FDA Warns – E. coli outbreak linked to supplier prompts 4Earth Farms to recall mixed vegetable products](https://trulaw.com/fda/fda-warns-e-coli-outbreak-linked-to-supplier-prompts-4earth-farms-to-recall-mixed-vegetable-products/): The California company 4Earth Farms announced a recall last Tuesday of several of their fresh and frozen mixed vegetable products due to concerns about possible contamination with E. coli O121:H19. According to the FDA, the recall is connected to a larger recall of carrots supplied by Grimmway Farms, Inc. - [FDA warns – Blue Ridge Beef recalls 2 lots of Puppy Mix logs after FDA testing detects Salmonella](https://trulaw.com/fda/fda-warns-blue-ridge-beef-recalls-2-lots-of-puppy-mix-logs-after-fda-testing-detects-salmonella/): The pet food company Blue Ridge Beef out of North Carolina issued a recall on Monday for two lots of their 2-pound Puppy Mix logs. FDA testing detected Salmonella in the recalled lots of puppy food. - [FDA Warns – Concern about exposure to NDLs, PCBAs, and PCBs prompts Baxter to issue a Medical Device Correction for their AK 98 Hemodialysis Machine](https://trulaw.com/fda/fda-warns-concern-about-exposure-to-ndls-pcbas-and-pcbs-prompts-baxter-to-issue-a-medical-device-correction-for-their-ak-98-hemodialysis-machine/): Just under two months ago, Baxter International issued an urgent correction for all of their AK 98 Hemodialysis Machines with less than 500 hours of runtime due to concerns about exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). According to the FDA, the announcement followed on the heels of similar recalls issued by other healthcare companies. - [FDA Warns – Baloian Farms recalls Pamela and PamPak branded cucumbers due to possible Salmonella contamination](https://trulaw.com/fda/fda-warns-baloian-farms-recalls-pamela-and-pampak-branded-cucumbers-due-to-possible-salmonella-contamination/): According to the FDA, Baloian Farms of Arizona has issued recall of their Pamela and PamPak branded whole cucumbers due to concerns about possible Salmonella contamination. The company announced the recall on November 29th after consulting with the FDA about the decision. - [FDA warns – Elekta recalls 1 lot of Disposable Biopsy Needle Kits after finding stainless steel debris inside the needles](https://trulaw.com/fda/fda-warns-elekta-recalls-1-lot-of-disposable-biopsy-needle-kits-after-finding-stainless-steel-debris-inside-the-needles/): Earlier this fall, Elekta issued a recall of one lot of their Disposable Biopsy Needle Kits after discovering debris inside the needle. The FDA has listed this as a Class 1 recall. - [FDA warns – MXBBB recalls UMARY Hyaluronic Acid tablets after FDA detects diclofenac and omeprazole in the supplement](https://trulaw.com/fda/fda-warns-mxbbb-recalls-umary-hyaluronic-acid-tablets-after-fda-detects-diclofenac-and-omeprazole-in-the-supplement/): The FDA recently announced the recall of MXBBB's UMARY Hyaluronic Acid tablets after laboratory testing detected two unlisted drugs in the supplement. MXBBB initiated the recall of 321 units of the supplement on Thursday, November 21st. - [FDA warns – Packaging error, undeclared wheat trigger recall of Sugar Foods’ Fresh Gourmet Tortilla Strips Santa Fe Style](https://trulaw.com/fda/fda-warns-packaging-error-undeclared-wheat-trigger-recall-of-sugar-foods-fresh-gourmet-tortilla-strips-santa-fe-style/): A packaging error has led Sugar Foods to recall at least one lot of their Fresh Gourmet Tortilla Strips Santa Fe Style. According to the recall notice posted by the FDA, the company initiated the recall after determining the product contains undeclared wheat. - [FDA warns – Citing potential motor failure, Draeger Inc. issues Urgent Medical Device Correction for their Atlan A350 and Atlan 350XL anesthesia workstations](https://trulaw.com/fda/fda-warns-citing-potential-motor-failure-draeger-inc-issues-urgent-medical-device-correction-for-their-atlan-a350-and-atlan-350xl-anesthesia-workstations/): The FDA notified the public last Tuesday of Draeger Inc.’s Class I recall of their Atlan A350 and Atlan 350XL anesthesia workstations. Issued on October 15th, the recall involves an urgent correction of the stipulated devices. - [FDA warns – Gaines Pet Treats LLC recalls 1 lot of Gaines Family Farmstead Chicken Strips after testing finds Salmonella](https://trulaw.com/fda/fda-warns-gaines-pet-treats-llc-recalls-1-lot-of-gaines-family-farmstead-chicken-strips-after-testing-finds-salmonella/): Concerns about possible salmonella contamination have led Gaines Pet Treats LLC to recall one lot of their Gaines Family Farmstead Chicken Strips. The FDA announced the recall Friday, November 22nd, on the heels of the company’s communication to consumers. - [FDA warns – Recall of “Kickin” Carrot Falafel Bites by Fabalish Inc. prompted by larger carrot recall linked to E. coli outbreak](https://trulaw.com/fda/fda-warns-recall-of-kickin-carrot-falafel-bites-by-fabalish-inc-prompted-by-larger-carrot-recall-linked-to-e-coli-outbreak/): Concerns about possible E. Coli contamination have prompted Fabalish Inc. to recall their “Kickin” Carrot Falafel Bites. The FDA published news of the recall on Wednesday, two days after the company issued their announcement. - [FDA warns – IHA Beverage recalls Super Brand Dried Cinnamon Powder after testing finds elevated lead levels](https://trulaw.com/fda/fda-warns-iha-beverage-recalls-super-brand-dried-cinnamon-powder-after-testing-finds-elevated-lead-levels/): According to the FDA, IHA Beverage out of California has issued a recall for its Super Cinnamon Powder (4oz) after lab testing found elevated levels of lead in the product. The company issued the recall on Monday, November 18th. - [FDA warns – Grimmway Farms whole and baby carrots implicated in E. Coli outbreak, recalled](https://trulaw.com/fda/fda-warns-grimmway-farms-whole-and-baby-carrots-implicated-in-e-coli-outbreak-recalled/): Grimmway Farms has issued a recall for multiple lots of whole and baby carrots sold under various brand names in the United States, Canada, and Puerto Rico. The FDA published notice of the recall on Tuesday, not long after the company's announcement. - [FDA warns – Asian Sesame Salad with Chicken Recalled by Wegmans Food Markets Due to Potential Presence of Egg](https://trulaw.com/fda/fda-warns-asian-sesame-salad-with-chicken-recalled-by-wegmans-food-markets-due-to-potential-presence-of-egg/): According to the U.S. Food and Drug Administration (FDA), Buffalo, New York-based Wegmans Food Markets has recalled its Large Asian Sesame Salad with Chicken and Asian Peanut Dressing because the product may contain egg, an undeclared allergen. - [FDA warns – Multiple injuries reported, Class 1 recall issued for VasoView HemoPro 1 and VasoView HemoPro 1.5](https://trulaw.com/fda/fda-warns-multiple-injuries-reported-class-1-recall-issued-for-vasoview-hemopro-1-and-vasoview-hemopro-1-5/): Almost two months ago, Getinge and Maquet Cardiovascular issued a Class 1 recall for the VasoView HemoPro Endoscopic Vessel Harvesting System. According to the FDA, the recall involved two models and multiple lots. - [FDA warns – Listeria contamination at production facility leads Savencia Cheese USA to recall 7 lots of soft-ripened cheese](https://trulaw.com/fda/fda-warns-listeria-contamination-at-production-facility-leads-savencia-cheese-usa-to-recall-7-lots-of-soft-ripened-cheese/): Last Monday, a major cheese manufacturer out of Pennsylvania recalled several varieties of soft-ripened cheeses after testing confirmed Listeria contamination in a production facility. According to the FDA, the recall applied to seven lots total of cheese sold under various brand names. - [FDA warns – Gilster Mary Lee Corp. recalls 2 lots of Bowl & Basket Onion Soup Mix due to undeclared egg](https://trulaw.com/fda/fda-warns-gilster-mary-lee-corp-recalls-2-lots-of-bowl-basket-onion-soup-mix-due-to-undeclared-egg/): The FDA notified the public on Tuesday of a new recall involving the Gilster Mary Lee Corporation out of Perryville, Missouri. The company says that the packaging on two lots of their Bowl & Basket Onion Soup Mix fails to list egg as an included ingredient. - [FDA warns – CIBUS Fresh recalls sandwiches made with Glenview Farms Spreadable Brie due to listeria concerns](https://trulaw.com/fda/fda-warns-cibus-fresh-recall-sandwiches-made-with-glenview-farms-spreadable-brie-due-to-listeria-concerns/): CIBUS Fresh is recalling three of their pre-packaged sandwiches after receiving notice that the cheese sourced for the products may have been contaminated with Listeria monocytogenes. According to the FDA, the company announced the recall on Wednesday, November 6. - [FDA warns – Packaging error, undeclared egg ingredients prompt Babcock Dairy to recall Orange Custard Chocolate Chip ice cream](https://trulaw.com/fda/fda-warns-packaging-error-undeclared-egg-ingredients-prompt-babcock-dairy-to-recall-orange-custard-chocolate-chip-ice-cream/): The FDA recently notified the public of Babcock Dairy's recall of 41 cases of their Orange Custard Chocolate Chip ice cream due to a labelling issue. The company says the product contains both eggs and yellow #5, neither of which are indicated in the list of ingredients. - [FDA warns – GE HealthCare receives new safety data, updates recommendations for EVair Compressors](https://trulaw.com/fda/fda-warns-ge-healthcare-receives-new-safety-data-updates-recommendations-for-evair-compressors/): The FDA recently issued updated recommendations for the GE HealthCare EVair Compressor after testing confirmed safe levels of formaldehyde emissions with use of the device. The update provides a follow up to GE HealthCare's Urgent Medical Device Correction notice sent to users last year. - [FDA warns – Dynarex Corporation recalls an additional 990 cases of Dynacare Baby Powder due to asbestos concerns](https://trulaw.com/fda/fda-warns-dynarex-corporation-recalls-an-additional-990-cases-of-dynacare-baby-powder-due-to-asbestos-concerns/): Concerns about asbestos have prompted the Dynarex Corporation to expand the recall they initiated in late September of Dynacare Baby Powder. According to the FDA, the renewed recall applies to an additional 990 cases of baby powder. - [FDA warns – HH Fresh Trading Corp recalls 480 cases of Taiwan Enoki mushrooms over concerns of Listeria contamination](https://trulaw.com/fda/fda-warns-hh-fresh-trading-corp-recalls-480-cases-of-taiwan-enoki-mushrooms-over-concerns-of-listeria-contamination/): A positive test for Listeria monocytogenes has prompted HH Fresh Trading Corp of California to recall 480 cases of Taiwan Enoki mushrooms. The FDA announced the recall on Saturday, November 2nd. - [FDA warns – Boulla LLC recalls ZoomMax and ZapMax supplements after detection of undeclared prescription drugs](https://trulaw.com/fda/fda-warns-boulla-llc-recalls-zoommax-and-zapmax-supplements-after-detection-of-undeclared-prescription-drugs/): The FDA recently notified the public of a recall initiated by the supplement company Boulla LLC of their ZoomMax and ZapMax capsules. The company announced the recall after FDA testing found undisclosed prescription drugs in the supplements. - [FDA warns – One Roof, LLC. recalls Atwater’s Spider Web Tarts due to presence of undeclared almond flour](https://trulaw.com/fda/fda-warns-one-roof-llc-recalls-atwaters-spider-web-tarts-due-to-presence-of-undeclared-almond-flour/): The discovery of undeclared almond flour has prompted One Roof, LLC., better known as Atwater's, to recall specific batches of their Spider Web Tarts. The FDA published notice of the recall on October 28, 2024. - [FDA warns – Percussionaire announces Class 1 recall of their Phasitron 5 breathing circuits due to concerns about nickel exposure](https://trulaw.com/fda/fda-warns-percussionaire-announces-class-1-recall-of-their-phasitron-5-breathing-circuits-due-to-concerns-about-nickel-exposure/): Concerns about nickel exposure have prompted Percussionaire to recall nine lots of their Phasitron 5 breathing circuits. According to the FDA, this is a Class I recall due to risk of serious injury with use of the device. - [FDA warns – Elevation Foods discovers labeling error, recalls Hannaford Seafood Salads with undisclosed soy ingredients](https://trulaw.com/fda/fda-warns-elevation-foods-discovers-labeling-error-recalls-hannaford-seafood-salads-with-undisclosed-soy-ingredients/): Discovery of an undiscovered allergen has prompted R. Walters LLC, known publicly as Elevation Foods, to recall 1,668 units of their Hannaford Seafood Salad. The FDA published notice of the company's announcement on Thursday, October 31st. - [FDA warns – Acme Smoked Fish Corporation recalls 1 lot of Kirkland Signature Smoked Salmon after testing detects Listeria](https://trulaw.com/fda/fda-warns-acme-smoked-fish-corporation-recalls-1-lot-of-kirkland-signature-smoked-salmon-after-testing-detects-listeria/): According to the FDA, Acme Smoked Fish Corporation is recalling 111 cases of Kirkland Signature Smoked Salmon from Costco stores in Florida. The company initiated the recall after lab testing confirmed the presence of Listeria monocytogenes in a sampling of the product. - [FDA warns – Risk of fire, burns prompts Urgent Medical Device Correction for Kinova’s Jaco Assistive Robotic Arm](https://trulaw.com/fda/fda-warns-risk-of-fire-burns-prompts-urgent-medical-device-correction-for-kinovas-jaco-assistive-robotic-arm/): The robotics company Kinova has issued an Urgent Medical Device Correction notice for their Jaco Assistive Robotic Arm due to fire and burn risks. The FDA considers this a Class 1 recall, since continued use of the device without the proposed corrections could cause serious injury or death. - [FDA warns – Grand Central Bakery in Seattle and Portland recalls multiple items after discovery of undeclared egg](https://trulaw.com/fda/fda-warns-grand-central-bakery-in-seattle-and-portland-recalls-multiple-items-after-discovery-of-undeclared-egg/): Grand Central Bakery in the Pacific Northwest is recalling several of their frozen pies and pre-made crusts due to the potential presence of undeclared eggs. The FDA published the notice on Saturday, October 26th, just one day after the company's announcement. - [FDA warns – Hologic, Inc. issues Class 1 recall of all models of BioZorb Markers due to risk of injury](https://trulaw.com/fda/fda-warns-hologic-inc-issues-class-1-recall-of-all-models-of-biozorb-markers-due-to-risk-of-injury/): As a follow-up to a device correction issued several months prior, Hologic, Inc. is now announcing a full product removal of all models of their BioZorb Markers after numerous reports of injury. The FDA is calling this a Class 1 recall. - [FDA warns – Dakota Tom’s Sandwiches recalls three sandwiches in response to nationwide BrucePac recall linked to Listeria outbreak](https://trulaw.com/fda/fda-warns-dakota-toms-sandwiches-recalls-three-sandwiches-in-response-to-nationwide-brucepac-recall-linked-to-listeria-outbreal/): Dakota Tom's Sandwiches out of South Dakota recently issued a voluntary recall of three of their sandwiches in response to a larger national recall involving one of the company's suppliers. According to the FDA, possible contamination with Listeria monocytogenes is at the center of the recall. - [FDA warns – Packaging error, undeclared allergens prompt recall of Con Yeager Spice Company’s Trail Bologna Processing Kits](https://trulaw.com/fda/fda-warns-packaging-error-undeclared-allergens-prompt-recall-of-con-yeager-spice-companys-trail-bologna-processing-kits/): According to the FDA, Con Yeager Spice Company is recalling one lot of Trail Bologna Meat Processing Kits due to a packing error that resulted in undeclared wheat and soy in the product. The company announced the recall on Monday, October 21. - [FDA warns – Medtronic plc issues Class 1 recall notification regarding impaired battery life in the MiniMed™ 600 and 700 series insulin pumps](https://trulaw.com/fda/fda-warns-medtronic-plc-issues-class-1-recall-notification-regarding-impaired-battery-life-in-the-minimed-600-and-700-series-insulin-pumps/): After receiving numerous customer reports of adverse health events, Medtronic plc of Ireland is issuing an urgent notification with updated instructions for its MiniMed™ 600 and 700 series insulin pumps. Due to the potential risk to consumers, the FDA is referring to Medtronic's notification as a Class 1 recall. - [FDA warns – Church Brothers LLC recalls 4 lots of green onions after Canadian Inspection Agency finds salmonella in sample](https://trulaw.com/fda/fda-warns-church-brothers-llc-recalls-4-lots-of-green-onions-after-canadian-inspection-agency-finds-salmonella-in-sample/): Church Brothers LLC is recalling at least four lots of green onions in the United States and Canada. The FDA reports that the Canadian Food Inspection Agency found evidence of Salmonella contamination in a sample of the product during a routine inspection. - [FDA warns – Reser’s Fine Foods recalls meal kits containing recalled BrucePac chicken due to probable Listeria contamination](https://trulaw.com/fda/fda-warns-resers-fine-foods-recalls-meal-kits-containing-recalled-brucepac-chicken-due-to-probable-listeria-contamination/): Reser’s Fine Foods recently recalled several of its meal kits in response to a larger nationwide recall of pre-cooked chicken products potentially contaminated by Listeria monocytogenes. As explained by the FDA, Reser's Fine Foods sourced the chicken for their meal kits from BrucePac, which is the company at the center of the larger recall. - [FDA warns – C&A Naturistics recalls AK Forte supplement after FDA analysis finds contamination with prescription drugs](https://trulaw.com/fda/fda-warns-ca-naturistics-recalls-ak-forte-supplement-after-fda-analysis-finds-contamination-with-prescription-drugs/): The California company C&A Naturistics is recalling its AK Forte supplement in response to a recent analysis that found undisclosed drugs in the product. According to the FDA, the company announced the recall last Thursday. - [FDA warns – Discovery of glass particulate prompts Staska Pharmaceuticals to recall one batch of their Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials](https://trulaw.com/fda/fda-warns-discovery-of-glass-particulate-prompts-staska-pharmaceuticals-to-recall-one-batch-of-their-ascorbic-acid-solution-for-injection-preservative-free-non-corn-500mg-ml-50ml-vials/): The FDA warned consumers and health care providers today regarding a serious recall initiated by Staska Pharmaceuticals, Inc. of one lot of their Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials. The company issued the recall last Thursday after discovering potential contamination with glass particulate. - [FDA warns – Tipical Latin Food Corp cites labeling issue, undeclared wheat in recall of Cachapa de Maiz sweet corn pancakes](https://trulaw.com/fda/fda-warns-tipical-latin-food-corp-cites-labeling-issue-undeclared-wheat-in-recall-of-cachapa-de-maiz-sweet-corn-pancakes/): A labeling error prompted Tipical Latin Food Corp of Miami to recall an unknown number of lots of their Cachapa de Maiz sweet corn pancakes, reports the FDA. The company says the label does not list wheat, which is an ingredient present in the product. - [FDA warns – Enoki King Mushroom Farm recalls one lot of Enoki Mushrooms due to contamination with Listeria monocytogenes](https://trulaw.com/fda/fda-warns-enoki-king-mushroom-farm-recalls-one-lot-of-enoki-mushrooms-due-to-contamination-with-listeria-monocytogenes/): According to the FDA, Enoki King Mushroom Farm has recalled one lot of Enoki Mushrooms due to possible contamination with Listeria monocytogenes. The company announced the recall on Friday, October 11th. - [FDA warns – Software issue prompts Class I recall of Zyno Medical’s Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps](https://trulaw.com/fda/fda-warns-software-issue-prompts-class-i-recall-of-zyno-medicals-z-800-z-800f-z-800w-and-z800wf-infusion-pumps/): According to the FDA, Zyno Medical issued a Class I recall on several of their infusion pumps after discovery of a potentially dangerous software malfunction. The company announced the recall on September 13th, 2024, notifying all users via an Urgent Medical Device Correction letter. - [FDA warns – Potential contamination prompts Youngstown Grape Distributors to recall two lots of Happy Moose Juice](https://trulaw.com/fda/fda-warns-youngstown-grape-distributors-recalls-two-lots-of-happy-moose-juice-due-to-potential-contamination/): Late last week, Youngstown Grape Distributors Inc. issued a voluntary recall of two lots of their Happy Moose Juice, citing a production error and an increased risk of bacterial contamination. The recall was initiated on October 4th, and the FDA shared the company’s announcement on Monday. - [FDA warns – Philips Respironics, Inc. issues Urgent Medical Device Correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators](https://trulaw.com/fda/fda-warns-philips-respironics-inc-issues-urgent-medical-device-correction-for-trilogy-evo-trilogy-evo-o2-trilogy-evo-universal-and-trilogy-ev300-ventilators/): Philips Respironics, Inc. has issued an Urgent Medical Device Correction for their series of Trilogy Evo ventilators due to concerns of aerosol deposits on the flow sensor when using in-line nebulizers. According to the FDA, the correction involves a field safety notice with updated guidelines and a list of precautions for customers using the ventilators. - [FDA warns – Jack and the Green Sprouts, Inc., recalls two lots of alfalfa sprouts after sampling detects Listeria](https://trulaw.com/fda/fda-warns-jack-and-the-green-sprouts-inc-recalls-two-lots-of-alfalfa-sprouts-after-sampling-detects-listeria/): The Wisconsin-based company Jack and the Green Sprouts, Inc., is recalling two lots of its Alfalfa and Alfalfa Onion sprouts due to possible contamination with Listeria monocytogenes. According to the FDA, the company announced the recall on October 4th. - [FDA warns – Mercury Medical announces urgent recall of Neo-Tee T-Piece Resuscitators due to problem with inline controller](https://trulaw.com/fda/fda-warns-mercury-medical-announces-urgent-recall-of-neo-tee-t-piece-resuscitators-due-to-problem-with-inline-controller/): As reported by the FDA, Mercury Medical has issued a Class I recall of their Neo-Tee T-Piece Resuscitators due to a potential malfunction with the inline controller. The company warns that continued use of the product could cause serious injury up to and including death. - [FDA warns – Lunds & Byerlys recalls 2 lots of L&B Lone Start Dip after discovery of possible mold contamination](https://trulaw.com/fda/fda-warns-lunds-byerlys-recalls-2-lots-of-lb-lone-start-dip-after-discovery-of-possible-mold-contamination/): The FDA recently notified the public of Lunds & Byerlys recall of two lots of their L&B Lone Star Dip after detection of mold in the product. The company announced the recall on Friday, October 4th. - [FDA warns – Sentec/Percussionaire issues Class 1 correction for its Phasitron 5 In-Line Valve during IPV after reports of injury](https://trulaw.com/fda/fda-warns-sentec-percussionaire-issues-class-1-correction-for-its-phasitron-5-in-line-valve-during-ipv-after-reports-of-injury/): In conjunction with the FDA, Sentec/Percussionaire has announced a Class 1 correction to the usage instructions for the Phasitron 5 In-Line Valve, which is used for Intrapulmonary Percussive Ventilation (IPV). The company released the corrections after receiving six reports of injury from patients using recalled device. - [FDA warns – Avole Inc. recalls Bacalaitos Criollos Codfish Frying Mix due to labeling error, undeclared fish](https://trulaw.com/fda/fda-warns-avole-inc-recalls-bacalaitos-criollos-codfish-frying-mix-due-to-labeling-error-undeclared-fish/): According to the FDA, the Puerto Rican company Avole Inc. (Productos Nita) is recalling at least one lot of their Bacalaitos Criollos Codfish Frying Mix due to the omission of “pollock” (fish) from the list of ingredients. For those with an allergy or sensitivity, consumption of the product will likely result in exposure to fish and fish products. - [FDA warns – Smiths Medical issues urgent correction for the paraPAC Plus P300 and P310 Ventilators](https://trulaw.com/fda/fda-warns-smiths-medical-issues-urgent-correction-for-the-parapac-plus-p300-and-p310-ventilators/): The FDA recently warned the public about a correction issued by Smiths Medical for its paraPAC Plus P300 and P310 Ventilators. The company requests that health care facilities follow all of the steps outlined in the correction recall to prevent injury and death while using the paraPAC Plus P300 and P310 Ventilators. - [FDA warns – Grace Imports, LLC. recalls three lots of snack mixes due to undeclared wheat](https://trulaw.com/fda/fda-warns-grace-imports-llc-recalls-three-lots-of-snack-mixes-due-to-undeclared-wheat/): The FDA recently notified the public of the recall initiated by Grace Imports, LLC., of three lots of snack mixes after determining the product may contain undeclared wheat. At the end of August, a supplier notified the company that the asafetida, which is an herb used in Indian food, likely contains wheat. The packaging for the recalled batches does not list wheat as an ingredient. - [FDA warns – ANSWERS recalls 4 lots of of beef and chicken dog food after FDA sampling finds listeria and salmonella](https://trulaw.com/fda/fda-warns-answers-recalls-4-lots-of-of-beef-and-chicken-dog-food-after-fda-sampling-finds-listeria-and-salmonella/): The FDA is reporting a recall initiated by Lystn, LLC., known on the market as ANSWERS, of four lots of dog food due to potential contamination with Salmonella and Listeria. The recall applies to specific lots of the company's beef and chicken dog foods. - [FDA warns – Manufacturing defect leads Freesius Kabi to recall 1 lot of Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site](https://trulaw.com/fda/fda-warns-manufacturing-defect-leads-freesius-kabi-to-recall-1-lot-of-ivenix-lvp-primary-administration-sets-dual-inlet-low-sorbing-needle-free-port-y-site/): According to the FDA, Freesius Kabi is recalling one lot of the Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site due to a serious manufacturing defect. Continued use of the product could result in injury or death. - [FDA warns – Truly Good Foods recalls lot of Grabeez The Big Cheese Snack Mix cups for undeclared tree nuts](https://trulaw.com/fda/fda-warns-truly-good-foods-recalls-lot-of-grabeez-the-big-cheese-snack-mix-cups-for-undeclared-tree-nuts/): According to the FDA, Truly Good Foods has issued a recall on one lot of their Grabeez The Big Cheese Snack Mix cups. The company says the label on the product does not list almonds and cashews, which are clearly present in the snack mix as packaged. - [FDA warns – Gilead Sciences, Inc. recalls one lot of Veklury® (remdesivir) for Injection after finding glass particulate](https://trulaw.com/fda/fda-warns-gilead-sciences-inc-recalls-one-lot-of-veklury-remdesivir-for-injection-after-finding-glass-particulate/): The FDA alerted the public Monday of a recent recall initiated by Gilead Sciences, Inc. of one lot of Veklury® (remdesivir) for Injection due to possible contamination with glass particulate. The company announced the recall on Friday, September 20th, after receiving a complaint from a consumer. - [FDA warns – Vail-Bon Jie Yang Wan Capsules recalled by 123Herbals LLC due to presence of Dexamethasone, Chlorpheniramine](https://trulaw.com/fda/fda-warns-vail-bon-jie-yang-wan-capsules-recalled-by-123herbals-llc-due-to-presence-of-dexamethasone-chlorpheniramine/): According to the FDA, Rosemead, California-based 123herbals has recalled all lots of its Vail-Bon Jie Yang Wan capsules out of concern that the products contain undeclared dexamethasone and chlorpheniramine. - [FDA warns – Dynarex Corporation recalls 62 cases of Dynacare Baby Power due to potential contamination with asbestos](https://trulaw.com/fda/fda-warns-dynarex-corporation-recalls-62-cases-of-dynacare-baby-power-due-to-potential-contamination-with-asbestos/): On Thursday, the FDA published an announcement released by Dynarex Corporation regarding a recall of 62 cases of their Dynacare Baby Powder. The company initiated the recall after FDA sampling detected asbestos in the product. - [FDA warns – Bionpharma Inc. recalls one lot of Atovaquone Oral Suspension, 750 mg per mL, due to Chonella contamination](https://trulaw.com/fda/fda-warns-bionpharma-inc-recalls-one-lot-of-atovaquone-oral-suspension-750-mg-per-ml-due-to-chonella-contamination/): According to the FDA, Bionpharma Inc. is recalling one lot of Atovaquone Oral Suspension, 750 mg per mL, after discovering Cohnella bacteria in the product. The Drug Safety Department of Bionpharma Inc. announced the recall on September 17, 2024. It applies to bottles produced on October 26, 2023, and released on December 05, 2023, with an expiration date of September 2025. - [FDA warns – Milo’s Poultry Farms, LLC. recalls all sizes and types of eggs due to Salmonella contamination linked to outbreak](https://trulaw.com/fda/fda-warns-milos-poultry-farms-llc-recalls-all-sizes-and-types-of-eggs-due-to-salmonella-contamination-linked-to-outbreak/): The FDA recently notified the public of a comprehensive egg recall for all eggs produced by Milo’s Poultry Farms, LLC. out of Wisconsin. The company announced the recall after officials detected Salmonella in samples taken from the environment where the eggs are produced. - [FDA Advises – Warning issued regarding increased risk of postoperative femoral fracture with use of CPT Hip System Femoral Stem](https://trulaw.com/fda/fda-advises-warning-issued-regarding-increased-risk-of-postoperative-femoral-fracture-with-use-of-cpt-hip-system-femoral-stem/): On Tuesday, the FDA published a warning related to Zimmer Biomet’s early July recall of its CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). The FDA cautions patients and healthcare professionals that the updated instructions provided by Zimmer Biomet are likely insufficient to address the problems noted in the recall. - [FDA Warns – Hammond’s Candies ids undeclared milk, recalls two lots of 4.5 oz. bags of Dark Chocolate Filled Mini Waffle Cones](https://trulaw.com/fda/fda-warns-hammonds-candies-ids-undeclared-milk-recalls-two-lots-of-4-5-oz-bags-of-dark-chocolate-filled-mini-waffle-cones/): The FDA recently warned the public of a recall initiated by Hammond’s Candies of two lots of its Dark Chocolate Filled Mini Waffle Cones due to the potential presence of undeclared milk. The company announced the recall after a customer complained of an allergic reaction after eating the product. - [FDA warns – Updated warning and recommendations issued for patients and health care providers regarding risk of liver injury when taking Veozah (fezolinetant)](https://trulaw.com/fda/fda-warns-updated-warning-and-recommendations-issued-for-patients-and-health-care-providers-regarding-risk-of-liver-injury-when-taking-veozah-fezolinetant/): On Thursday, the FDA issued a warning regarding the potential for “serious liver injury” in patients taking the medication Veozah (fezolinetant). Along with the warning, the FDA released updated recommendations regarding precautions health care professionals should take when prescribing Veozah and signs and symptoms patients should look for when taking the drug. - [FDA warns – Innovation Bakers, LLC recalls lot of 7-11 Fudge Brownies distributed in SoCal due to undeclared walnuts](https://trulaw.com/fda/fda-warns-innovation-bakers-llc-recalls-lot-of-7-11-fudge-brownies-distributed-in-socal-due-to-undeclared-walnuts/): The FDA notified the public Wednesday of a recall initiated by Innovation Bakers, LLC of one lot of its 7-11 Fudge Brownie product. The company attributes the recall to the undeclared presence of walnuts in the brownies. - [FDA warns – SoClean3+ device authorized for marketing despite lack of FDA approval for ozone devices to clean CPAP machines](https://trulaw.com/fda/fda-warns-soclean3-device-authorized-for-marketing-despite-lack-of-fda-approval-for-ozone-devices-to-clean-cpap-machines/): The FDA has authorized the SoClean company to market its SoClean3 device as its most recent product for sanitizing CPAP devices beyond the routine cleaning process outlined in all CPAP instruction manuals. Along with this authorization, the FDA is notifying the public of SoClean's 2023 recall, which involved a release of updated instructions and add-on equipment for the SoClean2 (UCP 187293000860) and SoClean3 (UDI (01)00858242007147). - [FDA warns – Eagle Produce LLC recalls lot of whole cantaloupes due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-eagle-produce-llc-recalls-lot-of-whole-cantaloupes-due-to-potential-salmonella-contamination/): According to the FDA, Eagle Produce LLC out of Scottsdale, AZ, is recalling one lot of Kandy-branded whole cantaloupe due to potential contamination with Salmonella. The recall applies to 224 cases of whole cantaloupe distributed and sold between August 13th and August 17th in Michigan, Missouri, Ohio, Texas and Virginia. - [FDA Warns – Medtronic recalls McGrath MAC and McGrath MAC EMS Video Laryngoscopes and issues updated instructions for use for a third model after reports of battery defect](https://trulaw.com/fda/fda-warns-medtronic-recalls-mcgrath-mac-and-mcgrath-mac-ems-video-laryngoscopes-and-issues-updated-instructions-for-use-for-a-third-model-after-reports-of-battery-defect/): On Thursday, the FDA released an announcement regarding Medtronic’s decision to recall two of its devices — the McGrath MAC Video Laryngoscope and the McGrath MAC EMS Video Laryngoscope. Additionally, Medtronic issued updated instructions for the Next-Generation McGrath MAC Video Laryngoscope, which they are not removing from distribution. - [FDA warns – Abbott Diabetes Care Inc. recalls three lots of sensors associated with the FreeStyle Libre 3 Continuous Glucose Monitoring System after reports of inaccurate readings](https://trulaw.com/fda/fda-warns-abbott-diabetes-care-inc-recalls-three-lots-of-sensors-associated-with-the-freestyle-libre-3-continuous-glucose-monitoring-system-after-reports-of-inaccurate-readings/): On Thursday, the FDA notified the public of a recall initiated by Abbott Diabetes Care Inc. of three lots of its FreeStyle Libre 3 sensor, which is a component of the company’s FreeStyle Libre 3 Continuous Glucose Monitoring System. The company says that the implicated sensor occasionally provides elevated glucose readings that are inaccurate, which can pose a health risk to patients with diabetes. - [FDA Warns – Sierra Stain LLC recalls water-based tattoo inks from Bloodline brand after detection of high levels of microorganisms](https://trulaw.com/fda/fda-warns-sierra-stain-llc-recalls-water-based-tattoo-inks-from-bloodline-brand-after-detection-of-high-levels-of-microorganisms/): According to the FDA, Carson City-based company Sierra Stain LLC recalled three shades of water-based tattoo inks from its Bloodline brand due to the presence of high levels of microorganisms. Sierra Stain announced the recall on August 23, 2024. - [FDA warns – Inari Medical issues correction recall with updated instructions for use of ClotTriever XL Catheter 30mm device](https://trulaw.com/fda/fda-warns-inari-medical-issues-correction-recall-with-updated-instructions-for-use-of-clottriever-xl-catheter-30mm-device/): The FDA recently notified the public of a recall issued by Inari Medical regarding updating instructions for use of its ClotTriever XL Catheter 30mm device after reports of injury and death. The recall does not involve the removal or discontinuation of the product itself, but rather pertains to guidelines regarding use of the product. - [FDA Warns – Unilever recalls 11 lots of single-serving Popsicle Jolly Rancher Frozen Confection Pop products after detection of undeclared milk](https://trulaw.com/fda/fda-warns-unilever-recalls-11-lots-of-single-serving-popsicle-jolly-rancher-frozen-confection-pop-products-after-detection-of-undeclared-milk/): Almost two weeks ago, the FDA notified the public of Unilever's recall of eleven lots of its single-serving Popsicle brand Jolly Rancher Frozen Confection Pop products. Unilever attributed the recall to the presence of undeclared milk in the popsicles. - [FDA warns – Asli Fine Foods of Woodridge, IL, announces recall of one lot of Asli cinnamon powder 7 oz due to lead contamination](https://trulaw.com/fda/fda-warns-asli-fine-foods-of-woodridge-il-announces-recall-of-one-lot-of-asli-cinnamon-powder-7-oz-due-to-lead-contamination/): The FDA is alerting the public to a recall of cinnamon initiated by Asli Fine Foods of Woodridge, IL. The company announced the recall of one lot of its 7 oz packets of Asli cinnamon powder after detection of lead in the product. - [FDA Alerts – Tandem Diabetes Care issues correction regarding recall of Apple iOS t:connect Mobile App version 2.7, urges upgrade to 2.8.2](https://trulaw.com/fda/fda-alerts-tandem-diabetes-care-issues-correction-regarding-recall-of-apple-ios-tconnect-mobile-app-version-2-7-urges-upgrade-to-2-8-2/): According to the FDA, Tandem Diabetes Care, Inc. issued a correction update earlier this month regarding an initial recall issued in March pertaining to the Apple iOS t:connect Mobile App software used with their t:slim X2 insulin pump with Control-IQ technology. The correction does not involve a recall of the t:slim X2 Insulin Pump device but instead pertains to the software used in conjunction with the pump. - [FDA Alerts – Authentik Fudge of Quebec recalls 3 lots of MONTREAL FUDGE due to potential mold contamination](https://trulaw.com/fda/fda-alerts-authentik-fudge-of-quebec-recalls-3-lots-of-montreal-fudge-due-to-potential-mold-contamination/): The FDA alerted the public last Thursday, August 22nd, of a recall involving three lots, or 840 units, of MONTREAL FUDGE produced by Authentik Fudge of Sainte-Julie, Quebec, Canada. The company issued the recall on Wednesday, August 21st, after receiving a complaint from a consumer and then finding multiple instances of mold contamination in the affected lots. - [FDA warns – Defibtech, LLC, recalls RMU-2000 ARM XR Chest Compression Device due to motor failure](https://trulaw.com/fda/fda-warns-defibtech-llc-recalls-rmu-2000-arm-xr-chest-compression-device-due-motor-failure/): The FDA has announced an urgent recall of the Defibtech RMU-2000 ARM XR Chest Compression Device due to a motor issue that could render the device inoperable. Defibtech, LLC, initiated the recall on July 12, 2024. - [FDA warns – 2 lots of Terrafina Golden Raisins recalled for presence of undeclared sulfites](https://trulaw.com/fda/fda-warns-2-lots-of-terrafina-golden-raisins-recalled-for-presence-of-undeclared-sulfites/): The FDA announced on Monday, August 26th, a recall initiated by Sunco & Frenchie LLC of two lots of its 10oz Terrafina Golden Raisins due to the potential presence of undeclared sulfites. Consumption of the product could cause a serious and potentially fatal allergic reaction in people with sulfite allergies. - [FDA warns – 2 lots of B. Braun 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers recalled due to potential presence of particulates, container leaks](https://trulaw.com/fda/fda-warns-2-lots-of-b-braun-0-9-sodium-chloride-for-injection-usp-1000-ml-in-e3-containers-recalled-due-to-potential-presence-of-particulates-container-leaks/): According to the FDA, B. Braun Medical Inc. (B. Braun), of Bethlehem, Pennsylvania, has recalled two lots of its 0.9 Sodium Chloride for Injection USP 1000 mL in E3 containers because the product may contain particulate matter, and its containers may potentially leak fluid. - [FDA warns – Single batch of CVS Health, H-E-B Baby Premium Infant Formula with Iron Milk-Based Powder recalled due to elevated Vitamin D](https://trulaw.com/fda/fda-warns-single-batch-of-cvs-health-h-e-b-baby-premium-infant-formula-with-iron-milk-based-powder-recalled-due-to-elevated-vitamin-d/): Perrigo Company plc, of Dubin, Ireland, and Allegan, Michigan, has recalled 16,500 cans of CVS Health and H-E-B Baby-branded Premium Infant Formula with Iron Milk-Based Powder because the product was found to contain an excessive level of Vitamin D, reports the FDA. - [FDA warns – Correction of 8,186 Vivo 45 LS ventilator devices issued due to potential for short-term heightened levels of formaldehyde exposure](https://trulaw.com/fda/fda-warns-correction-of-8186-vivo-45-ls-ventilator-devices-issued-due-to-potential-for-short-term-heightened-levels-of-formaldehyde-exposure/): Breas Medical has announced a nationwide correction of 8,186 Vivo 45 LS ventilator devices after internal testing determined that the product may be putting users at risk for exposure of short term heightened levels of formaldehyde, reports the FDA. - [FDA warns – Yummy Swirly Ices line recalled due to potential traces of undeclared milk](https://trulaw.com/fda/fda-warns-yummy-swirly-ices-line-recalled-due-to-potential-traces-of-undeclared-milk/): According to the FDA, Edison, New Jersey-based Yummy Foods has recalled its line of Yummy Swirly Ices, marketed as non-dairy products, due to the potential presence of milk, a major allergen not listed on the ingredient list. - [FDA alerts to Class I recall of CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump software due to multiple issues, risk of major injury and death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-cadd-solis-and-cadd-solis-vip-ambulatory-infusion-pump-software-due-to-multiple-issues-risk-of-major-injury-and-death/): The FDA is warning consumers that CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps are in need of software corrections due to multiple problems that have been identified in outdated software. - [FDA warns – 477 cases, 2 varieties of Prime Foods Egg Custard Steamed Buns recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-477-cases-2-varieties-of-prime-foods-egg-custard-steamed-buns-recalled-due-to-undeclared-sesame/): Brooklyn, New York-based Prime Foods Processing LLC has recalled 477 cases of its Egg Custard Steamed Buns in two varieties because the products may contain sesame, a major allergen not listed on its packaging, reports the FDA. - [FDA warns – Single lot of Heparin Sodium in 0.9% Sodium Chloride Injection recalled due to potentially dangerous endotoxin levels](https://trulaw.com/fda/fda-warns-single-lot-of-heparin-sodium-in-0-9-sodium-chloride-injection-recalled-due-to-potentially-dangerous-endotoxin-levels/): According to the FDA, Baxter International Inc., of Deerfield, Illinois, has recalled lot number N008235 of its Heparin Sodium in 0.9% Sodium Chloride Injection after issues with a bacterial endotoxin test revealed a potential for elevated endotoxin levels in the batch. - [FDA warns – “Cold Smoked Capelin” recalled by North Fish USA Inc. due to potential Clostridium botulinum contamination](https://trulaw.com/fda/fda-warns-cold-smoked-capelin-recalled-by-north-fish-usa-inc-due-to-potential-clostridium-botulinum-contamination/): According to the FDA, Hallandale, Florida-based North Fish USA Inc. has recalled its 9-ounce packages of imported "Cold Smoked Capelin" following a routine inspection conducted by New York State Department of Agriculture and Markets Foods Inspectors and then a later analysis by staff from Food Laboratory. - [FDA warns – Single lot of Full Circle Market Coconut Chocolate Almond Crunch Non-Dairy Frozen Dessert recalled due to mislabeling, undeclared cashew](https://trulaw.com/fda/fda-warns-single-lot-of-full-circle-market-coconut-chocolate-almond-crunch-non-dairy-frozen-dessert-recalled-due-to-mislabeling-undeclared-cashew/): G.S. Gelato & Desserts, Inc., of Fort Walton Beach, Florida, has recalled a single lot of its Full Circle Market-branded Coconutmilk Chocolate Almond Crunch Non-Dairy Frozen Dessert because the product contains cashew, a major allergen not disclosed due to a mislabeling, reports the FDA. - [FDA alerts to Class I recall of Medtronic NIM Vital Nerve Monitoring System due to possibility of false negative response](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-medtronic-nim-vital-nerve-monitoring-system-due-to-possibility-of-false-negative-response/): The FDA is informing the public that Medtronic has issued a corrective recall for its NIM Vital Nerve Monitoring System after receiving reports of false negative responses. While the recall does not involve a removal of the product from places of their use or sale, consumers should be aware that use of an uncorrected product could cause major injury or even death. - [FDA warns – 640 packs of Bikano Moong Dal, 350g, recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-640-packs-of-bikano-moong-dal-350g-recalled-due-to-potential-salmonella-contamination/): Hayward, California-based Thal Golden Spices Inc. has recalled 640 packs of its Bikano-branded Moong Dal, 350g, after the company learned that the product was released on the market "without proper lab results," according to the FDA, and therefore has the potential to be contaminated with the organism Salmonella. - [FDA warns – Lunds & Byerlys fresh guacamole products recalled due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-lunds-byerlys-fresh-guacamole-products-recalled-due-to-potential-listeria-contamination/): Minneapolis Minnesota-based Metro Produce Distributors Inc. has recalled all Lunds & Byerlys-branded fresh guacamole products under use-by date August 2, 2024, after a routine sampling conducted by the company indicated that the finished products may have traces of Listeria monocytogenes, reports the FDA. - [FDA alerts to health risks linked to defective packaging of Exactech Joint Replacement Devices](https://trulaw.com/fda/fda-alerts-to-health-risks-linked-to-defective-packaging-of-exactech-joint-replacement-devices/): The U.S. Food and Drug Administration (FDA) is calling to attention a March 23, 2024 recall of Exactech joint replacement devices that were manufactured from 2004 to August 2021. Officials say a number of the devices (joint replacements for knees, ankles, and hips) came in defective packaging that lacked an oxygen barrier layer meant to keep the devices from oxidizing. - [FDA warns – Marabou Sea Salt chocolate bar, 200g, recalled by BonBon due to undeclared almonds, wheat, nuts](https://trulaw.com/fda/fda-warns-marabou-sea-salt-chocolate-bar-200g-recalled-by-bonbon-due-to-undeclared-almonds-wheat-nuts/): New York, New York-based BonBon - A Swedish Candy Co. has recalled all Marabou Sea Salt chocolate bars after batches of the product were found to contain almonds, wheat, and nuts--major allergens not sufficiently disclosed on the packaging's ingredient label, according to the FDA. - [FDA warns – Spice Class brand Ground Cinnamon recalled by American Spices, LLC due to potential for elevated lead levels](https://trulaw.com/fda/fda-warns-spice-class-brand-ground-cinnamon-recalled-by-american-spices-llc-due-to-potential-for-elevated-lead-levels/): According to the FDA, Ozone Park, New York-based American Spices, LLC, has recalled its Spice Class brand Ground Cinnamon after an analysis performed by New York State Department of Agriculture and Markets (NYSAGM) showed the product to contain high than acceptable levels of lead. - [FDA alerts to Class I recall of Mega Soft Universal Patient Return Electrode due to potential burns, patient use updates](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-mega-soft-universal-patient-return-electrode-due-to-potential-burns-patient-use-updates/): The FDA is informing consumers that four devices are included in Megadyne Medical Product, Inc.'s recall of Mega Soft Universal Patient Return Electrodes because the Instructions for Use and product labeling need to be updated to restrict device use to patients aged 12 and older. - [FDA warns – Multiple packaged vegetable products sold at Kroger recalled due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-multiple-packaged-vegetable-products-sold-at-kroger-recalled-due-to-potential-listeria-contamination/): According to the FDA, as many as 19 different packaged vegetable products have been recalled by Supreme Service Solutions LLC because of a potential Listeria monocytogenes contamination. Announced by the company on July 26, 2024, the action concerns Supreme Produce-branded items that originated from Weirs Farm Inc. and distributed to Kroger retail stores across five U.S. states: Illinois, Indiana, Michigan, Missouri, and Ohio. - [FDA warns – Single-lot recall of Hikma Acetaminophen Injection, 1000mg/100mL extended to consumer level](https://trulaw.com/fda/fda-warns-single-lot-recall-of-hikma-acetaminophen-injection-1000mg-100ml-extended-to-consumer-level/): The FDA is advising consumers that Hikma Pharmaceuticals PLC (Hikma, Group) has extended its retail-level and single-lot recall of Acetaminophen Injection, 1000mg/100mL (10mg/mL) to the consumer level, per an update on the agency's website on July 22, 2024. - [FDA warns – Single lot of Van Leeuwen Vegan Pumpkin Cinnamon Roll Non-Dairy Frozen Dessert recalled due to undeclared peanuts](https://trulaw.com/fda/fda-warns-single-lot-of-van-leeuwen-vegan-pumpkin-cinnamon-roll-non-dairy-frozen-dessert-recalled-due-to-undeclared-peanuts/): Van Leeweun Ice Cream, headquartered in Brooklyn, New York, has recalled pints of its Vegan Pumpkin Cinnamon Roll under lot number 24V094 because the finished product may contain peanuts, an allergen not declared on its ingredient panel, reports the FDA. - [FDA warns – Freshire Farms Jalapeños, Green Peppers, Green Beans recalled by Aldi due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-freshire-farms-jalapenos-green-peppers-green-beans-recalled-by-aldi-due-to-potential-listeria-contamination/): Batavia, Illinois-based Aldi Inc., in collaboration with Wiers Farm, Inc. and R.S. Hanline Co Inc., has recalled Freshire Farms jalapeños, green peppers, and green beans because the organism Listeria monocytogenes may be present on the products, reports the FDA. - [FDA warns – ALB Flavor Ground Cinnamon recalled due to potential for elevated lead levels](https://trulaw.com/fda/fda-warns-alb-flavor-ground-cinnamon-recalled-due-to-potential-for-elevated-lead-levels/): According to the FDA, Bronx, New York-based ALB-USA Enterprises, Inc. has recalled its ALB Flavor-branded Cinnamon Powder after an analysis by the Connecticut Agriculture Experiment Station (CAES) indicated that the product may contain above-normal levels of lead. - [FDA warns – Single batch of St. Jerome cheese recalled by Kenny’s Farmhouse Cheese due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-single-batch-of-st-jerome-cheese-recalled-by-kennys-farmhouse-cheese-due-to-potential-listeria-contamination/): Austin, Kentucky-based Kenny's Farmhouse Cheese has recalled batch 231129 of its St. Jerome cheese after routine testing conducted by the Kentucky Department of Public Health showed the organism Listeria monocytogenes to be present in a single package, reports the FDA. - [FDA warns – Single lot of Healthy Living OTC Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets recalled due to mislabeling](https://trulaw.com/fda/fda-warns-single-lot-of-healthy-living-otc-migraine-relief-acetaminophen-250mg-aspirin-250mg-caffeine-65mg-tablets-recalled-due-to-mislabeling/): East Windsor, New Jersey-based Aurobindo Pharma USA, Inc. has recalled a single lot of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets on behalf of AuroHealth because the product does not have a manufacturer label, reports the FDA. - [FDA warns – 1-pound packages of shelled walnuts recalled by Stutz Packing Co. due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-1-pound-packages-of-shelled-walnuts-recalled-by-stutz-packing-co-due-to-potential-listeria-contamination/): Indio, California-based Stutz Packing Company has recalled its 1-pound bags of shelled walnuts because a potential Listeria monocytogenes contamination has been identified in the product, reports the FDA. - [FDA warns – Volara System Single-Patient Use Circuit recalled by Baxter due to risk of ventilator gas flow leak](https://trulaw.com/fda/fda-warns-volara-system-single-patient-use-circuit-recalled-by-baxter-due-to-risk-of-ventilator-gas-flow-leak/): According to the FDA, Baxter International Inc., of Deerfield, Illinois, has recalled certain lots of its Volara system single-patient use circuit and blue ventilator adapter assembly because of a potential device defect. - [FDA warns – Single lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) recalled due to mislabeling](https://trulaw.com/fda/fda-warns-single-lot-of-clonazepam-orally-disintegrating-tablets-usp-c-iv-recalled-due-to-mislabeling/): According to the FDA, Malvern, Pennsylvania-based Endo, Inc announced that a single lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets has been recalled by one of its subsidiaries, Endo USA, Inc., because the product carton may feature the incorrect strength. - [FDA warns – Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules recalled due to undeclared Diclofenac and Omeprazole](https://trulaw.com/fda/fda-warns-umary-acido-hialuronica-suplemento-alimenticio-850-mg-capsules-recalled-due-to-undeclared-diclofenac-and-omeprazole/): Chula Vista, California-based SoloVital.com has recalled all lots of its 30-caplet bottles of Umary Acido Hialuronica, Suplemento Alimenticio because the product has been found to contain two undeclared drug ingredients: diclofenac and omeprazole. - [FDA alerts to Class I recall of certain Bausch + Lomb I-Pack Injection Kits due to risk of non-sterility](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-certain-bausch-lomb-i-pack-injection-kits-due-to-risk-of-non-sterility/): According to the FDA, Bausch + Lomb/Synergetics Inc. has recalled four lots of its Bausch + Lomb I-Pack Injection Kit because officials are unable to verify the full sterilization of the products. Because of the risk of serious injury or death posed by the use of a potentially non-sterile product, the recall has been labeled Class I, the most serious type. - [FDA warns – Limited quantity of Whole and Salad Cucumbers recalled by Wiers Farm, Inc. due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-limited-quantity-of-whole-and-salad-cucumbers-recalled-by-wiers-farm-inc-due-to-potential-trace-of-listeria/): Wiers Farm, Inc., of Willard, Ohio, has announced a limited recall of whole cucumbers (under pack date June 5, 2024) and bagged salad cucumbers (under pack dates June 5 and 6, 2024) because the products may be contaminated with Listeria monocytogenes, reports the FDA. - [FDA warns – 4 lots of Al’Fez Natural Tahini in 5.6oz jars recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-4-lots-of-alfez-natural-tahini-in-5-6oz-jars-recalled-due-to-potential-salmonella-contamination/): According to the FDA, AB World Foods US, Inc. has recalled four production lots of its Al'Fez Natural Tahini in 5.6-ounce jars because of concerns that the products may contain the organism Salmonella. - [FDA warns – Life2000 Ventilater recalled by Baxter due to potential damage to battery charger dongle, risk of serious injury](https://trulaw.com/fda/fda-warns-life2000-ventilater-recalled-by-baxter-due-to-potential-damage-to-battery-charger-dongle-risk-of-serious-injury/): The FDA is informing consumers of an Urgent Medical Device Recall announced by Baxter International Inc. regarding its Life2000 ventilators that come with an attached battery charger dongle. - [FDA warns – Hill Country Fare Mustard Potato Salad recalled by Reser’s Fine Foods due to potential presence of foreign material](https://trulaw.com/fda/fda-warns-hill-country-fare-mustard-potato-salad-recalled-by-resers-fine-foods-due-to-potential-presence-of-foreign-material/): Reser's Fine Foods, headquartered in Beaverton, Oregon, has recalled its 48-ounce (3-pound) containers of Hill Country Fare Mustard Potato Salad under "Use By" date "JUL/26/24" because the product may contain hard plastic foreign material, reports the FDA. - [FDA alerts to Class I recall of HeartMate LVAS System Monitor due to screen issues, risk of pump stop](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-heartmate-lvas-system-monitor-due-to-screen-issues-risk-of-pump-stop/): Abbott Medical has announced a Class I recall of its HeartMate LVAS System Monitor under all lots/serial numbers because a correction needs to be made to the Left Ventricular Assist System (LVAS) monitor, according to the FDA. - [FDA warns – Urban River Spirits non-alcoholic mixes recalled due to possible under-processing](https://trulaw.com/fda/fda-warns-urban-river-spirits-non-alcoholic-mixes-recalled-due-to-possible-under-processing/): According to a company announcement featured on the FDA website on July 3, 2024, Urban River Spirits has voluntarily recalled its non-alcoholic drink mixes because the products may be under-processed and therefore may present a safety concern. - [FDA warns – Sun Seed Vita Prima Hedgehog Food recalled by Vitakcraft Sun Seed due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-sun-seed-vita-prima-hedgehog-food-recalled-by-vitakcraft-sun-seed-due-to-potential-salmonella-contamination/): Weston, Ohio-based Vitakraft Sun Seed Inc. has recalled 13 lots of its Sun Seed Vita Prima Hedgehog Food and Vitakraft Vita Smart Hedgehog Food because the products may be contaminated with the organism Salmonella, reports the FDA. - [FDA alerts to updates in use instructions for BiPAP V30, BiPAP A30, BiPAP A40 due to interrupted therapy](https://trulaw.com/fda/fda-alerts-to-updates-in-use-instructions-for-bipap-v30-bipap-a30-bipap-a40-due-to-interrupted-therapy/): The FDA is informing consumers of recent updates to a March 26, 2024 recall of three Philips Respironics, Inc. ventilators--BiPAP V30, BiPAP A30, and BiPAP A40--because of a failure in the device's Ventilator Inoperative alarm, which may result in interrupted or loss of therapy. - [FDA warns – Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K recalled by American Health Packaging](https://trulaw.com/fda/fda-warns-potassium-chloride-extended-release-capsules-usp-750-mg-10-meq-k-recalled-by-american-health-packaging/): According to the FDA, 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, under the Blue Point Laboratories brand, has been recalled by American Health Packaging due to the product's failed dissolution. - [FDA warns – Viva Raw recalls 5 dog and cat food products due to listeria contamination](https://trulaw.com/fda/fda-warns-viva-raw-recalls-5-dog-and-cat-food-products-due-to-listeria-contamination/): Hillsborough, North Carolina-based Viva Raw LLC is voluntarily recalling certain dog and cat foods due to contamination with Listeria monocytogenes which is considered a potential health risk to people and pets, the FDA reports. - [FDA warns – Terrafina brand Macadamia in the Raw recalled by Sunco & Frenchie LLC due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-terrafina-brand-macadamia-in-the-raw-recalled-by-sunco-frenchie-llc-due-to-potential-trace-of-salmonella/): Pine Brook, New Jersey-based Sunco & Frenchie LLC has recalled its 6-ounce plastic containers of Macadamia in the Raw, labeled under the Terrafina brand, because of a potential Salmonella contamination, reports the FDA. - [FDA warns – Aldi Bakeshop Chocolate Chip Muffin, 4 Count recalled by FGF Brands Inc. due to undeclared walnuts](https://trulaw.com/fda/fda-warns-aldi-bakeshop-chocolate-chip-muffin-4-count-recalled-by-fgf-brands-inc-due-to-undeclared-walnuts/): According to the FDA, 11830 cases of Aldi Bakeshop Chocolate Chip Muffin, sold in 4-count containers, has been recalled by the Toronto, Ontario-based company FGF Brands Inc. because of undeclared walnuts. - [FDA warns – 114 batches of Glenmark Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K recalled due to health risk](https://trulaw.com/fda/fda-warns-114-batches-of-glenmark-potassium-chloride-extended-release-capsules-usp-750-mg-10-meq-k-recalled-due-to-health-risk/): Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc., USA, has recalled 114 batches of its Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, because of the product's failure to dissolve, reports the FDA. - [FDA warns – Deluxe Roasted & Salted Mixed Nuts recalled by DSD Merchandisers due to undeclared peanut](https://trulaw.com/fda/fda-warns-deluxe-roasted-salted-mixed-nuts-recalled-by-dsd-merchandisers-due-to-undeclared-peanut/): DSD Merchandisers, LLC is voluntarily recalling is voluntarily recalled its product Deluxe Roasted & Salted Mixed Nuts because it contains undeclared peanuts, posing a risk to those allergic to peanuts, according to the FDA. - [FDA warns – Barkworthies, Best Bully Sticks Green Tripe dog treats recalled due to potential presence of foreign metals](https://trulaw.com/fda/fda-warns-barkworthies-best-bully-sticks-green-tripe-dog-treats-recalled-due-to-potential-presence-of-foreign-metals/): TDBBS LLC, of Richmond, Virginia, has recalled 3,551 bags of Green Tripe dog treats, sold under the Barkworthies and Best Bully Sticks brands, because the products may contain foreign metal objects, warns the FDA. - [FDA warns – Snapchill canned coffee products recalled due to potential growth of Clostridium botulinum](https://trulaw.com/fda/fda-warns-snapchill-canned-coffee-products-recalled-due-to-potential-growth-of-clostridium-botulinum/): The U.S. Food and Drug Administration (FDA) is warning consumers that Green Bay, Wisconsin-based Snapchill LLC (Snapchill) has recalled all of its canned coffee products because the company's current manufacturing process puts its low-acid canned foods at risk of developing or producing the deadly botulinum toxin. - [FDA alerts to Class I recall of MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-megadyne-mega-soft-pediatric-patient-return-electrodes/): The FDA is advising healthcare providers that Megadyne has recalled its MEGADYNE MEGA SOFT Pediatric Patient Return Electrode because use of the device has been found to cause burns. The recall has been identified as the most serious type (Class I) because product use may lead to a major injury or death. - [FDA warns – Hudson Harvest Tomato Basil Sauce recalled due to potential under-processing, spoilage](https://trulaw.com/fda/fda-warns-hudson-harvest-tomato-basil-sauce-recalled-due-to-potential-under-processing-spoilage/): Germantown, New York-based Hudson Harvest has recalled its Hudson Harvest Tomato Basil Sauce after receiving a number of reports indicating that the product may be under-processed, according to the FDA. - [FDA warns – 25 oz bags of Arepa de Choclo/Chocolo recalled by Villa Nueva Interservices LLC due to undeclared milk](https://trulaw.com/fda/fda-warns-25-oz-bags-of-arepa-de-choclo-chocolo-recalled-by-villa-nueva-interservices-llc-due-to-undeclared-milk/): Lakeworth, Florida-based Villa Nueva Interservices LLC has recalled its 25-ounce bags of Arepa de Choclo/Chocolo due to the presence of milk, a major allergen not declared on the product's ingredient panel, reports the FDA. - [FDA alerts to Class I recall of Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to device defect](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-medline-sub-g-endotracheal-tube-with-subglottic-suctioning-due-to-device-defect/): The FDA is notifying consumers that Medline Industries, LP has recalled its Medline Sub-G Endotracheal Tube with Subglottic Suctioning because of a device defect that causes the inflation tube and other components to detach or tear from the main tube. - [FDA warns – 51 bottles of Nature’s Wonderland Thyroid Formula recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-51-bottles-of-natures-wonderland-thyroid-formula-recalled-due-to-potential-salmonella-contamination/): Philadelphia, Pennsylvania-based Penn Herb Company Ltd has recalled 51 bottles of Nature's Wonderland Thyroid Formula after learning that the products may be contaminated with the organism Salmonella, reports the FDA. - [FDA warns – Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) recalled due to above-acceptable mold count](https://trulaw.com/fda/fda-warns-suntegrity-impeccable-skin-sunscreen-foundation-multiple-shades-recalled-due-to-above-acceptable-mold-count/): Suntegrity Skincare, of Las Vegas, Nevada, has voluntarily recalled 9 lots of its Suntegrity Impeccable Skin Sunscreen Foundation in multiple shades because the microbiological mold count (of the species Aspergillus Sydowii) in some tubes was found to be "higher than acceptable," reports the FDA. - [FDA warns – Discovery of microbial contamination leads to recall of Homeopathic StellaLife Oral Care Spray, Unflavored and Advanced Formula Peppermint Oral Care Rinse](https://trulaw.com/fda/fda-warns-discovery-of-microbial-contamination-leads-to-recall-of-homeopathic-stellalife-oral-care-spray-unflavored-and-advanced-formula-peppermint-oral-care-rinse/): Yonkers, New York-based HomeoCare Laboratories Inc. has announced that two batches of its Homeopathic StellaLife Oral Care products were voluntarily recalled at the consumer level because of a microbial contamination, according to the FDA. - [FDA warns – 4 oz containers of Baby Arugula recalled by Green Life Farms due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-4-oz-containers-of-baby-arugula-recalled-by-green-life-farms-due-to-potential-salmonella-contamination/): Green Life Farms, of Lake Worth, Florida, has recalled a single lot of its Baby Arugula, packaged in 4-ounce containers, because the products may contain traces of the organism Salmonella, reports the FDA. - [FDA alerts to Medtronic’s Class I recall of StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2. and 1.0.1 due to software error](https://trulaw.com/fda/fda-alerts-to-medtronics-class-i-recall-of-stealthstation-s8-application-versions-1-2-0-1-1-0-1-0-3-1-0-2-and-1-0-1-due-to-software-error/): Consumers and medical professionals should be advised that a recall impacting five versions of Medtronic's StealthStation S8 Application has been identified by the FDA as Class I, the most serious type. Officials said a software error could result in incorrect measurements during cranial surgery, which could then cause major injuries or death. - [FDA warns – New Seasons Market recalls Strawberry Rhubarb Bakewell Tart due to undeclared almonds](https://trulaw.com/fda/fda-warns-new-seasons-market-recalls-strawberry-rhubarb-bakewell-tart-due-to-undeclared-almonds/): Portland, Oregon-based New Seasons Market has recalled its Strawberry Rhubarb Bakewell Tart because it contains almond, an allergen not declared on the product ingredient list. - [FDA warns – Whole cucumbers recalled by Fresh Start Produce Sales, Inc. due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-whole-cucumbers-recalled-by-fresh-start-produce-sales-inc-due-to-potential-salmonella-contamination/): According to the FDA, bulk cartons of whole cucumbers have been recalled by Delray, Florida-based Fresh Start Produce Sales, Inc., because the products may be contaminated with the organism Salmonella. - [FDA warns – Crecelac Infant 0-12 and Farmalac 0-12, 012 Low lactose recalled by Dairy Manufacturers Inc. due to non-compliance](https://trulaw.com/fda/fda-warns-crecelac-infant-0-12-and-farmalac-0-12-012-low-lactose-recalled-by-dairy-manufacturers-inc-due-to-non-compliance/): On May 24, 2024, Prosper, Texas-based Dairy Manufacturers Inc. announced a voluntary recall of all lots of US-distributed Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0-12 Low lactose formulas because the products were found to be out of compliance with FDA requirements outlined under the agency's section 21 CFR 106.110 New Infant formula registration. - [FDA warns – Buprenorphine Hydrochloride Injection Carpuject™ Units and Labetalol Hydrochloride Injection, USP Carpuject™ Units recalled by Hospira due to potential packaging issue](https://trulaw.com/fda/fda-warns-buprenorphine-hydrochloride-injection-carpuject-units-and-labetalol-hydrochloride-injection-usp-carpuject-units-recalled-by-hospira-due-to-potential-packaging-issue/): According to the FDA, Hospira Inc., a Pfizer company based in New York, New York, has voluntarily recalled certain lots of its Buprenorphine Hydrochloride Injection Carpuject™ Units and its Labetalol Hydrochloride Injection, USP Carpuject™ Units. - [FDA warns – 8oz bags of Pop a Nosh Mixed Munch Regular and Honey BBQ snacks recalled due to undeclared wheat](https://trulaw.com/fda/fda-warns-8oz-bags-of-pop-a-nosh-mixed-munch-regular-and-honey-bbq-snacks-recalled-due-to-undeclared-wheat/): Brooklyn, New York-based AMB Food Inc. has recalled its 8-ounce bags of Pop a Nosh Mixed Munch Regular and Honey BBQ snacks because the products contain wheat, a major allergen not disclosed on an ingredient panel. - [FDA warns – 2 lots of Docetaxel Injection, USP recalled by Sagent Pharmaceuticals due to potential trace of particulate matter](https://trulaw.com/fda/fda-warns-2-lots-of-docetaxel-injection-usp-recalled-by-sagent-pharmaceuticals-due-to-potential-trace-of-particulate-matter/): Sagent Pharmaceuticals, of Schaumburg, Illinois, has voluntarily recalled two lots of Docetaxel Injection, USP, in 80 mg per 8 mL multi-dose vials as well as in 160 mg per 16 mL multi-dose vials, because particulate matter may be found in the stopper of the product. - [FDA warns – Palmer Candy Company updates recall to include more best-by dates, 2 more items due to Salmonella risk](https://trulaw.com/fda/fda-warns-palmer-candy-company-updates-recall-to-include-more-best-by-dates-2-more-items-due-to-salmonella-risk/): A May 6, 2024 press release informing the public of Palmer Candy Company's recall of white confectionary products has since been updated to include two more items, as well as additional best-by dates of six products previously included, according to the FDA. - [FDA alerts to Class I recall of Twin Tube by Vyaire Medical, Inc. due to risk of malfunction, choking hazard](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-twin-tube-by-vyaire-medical-inc-due-to-risk-of-malfunction-choking-hazard/): According to the FDA, Vyaire Medical, Inc.'s April 8, 2024, recall of its Twin Tube has been identified as Class I, the most serious type, because use of the product could lead to major injuries or death. - [FDA warns – 315 bags of Pedigree® Adult Complete Nutrition Grilled Steak & Vegetable Flavor Dry Dog Food recalled due to potential foreign matter](https://trulaw.com/fda/fda-warns-315-bags-of-pedigree-adult-complete-nutrition-grilled-steak-vegetable-flavor-dry-dog-food-recalled-due-to-potential-foreign-matter/): According to the FDA, Mars Petcare US, of Franklin, Tennessee, has recalled 315 44-pound bags of Pedigree® Adult Complete Nutrition Grilled Steak & Vegetable Flavor Dry Dog Food because the bag may contain loose pieces of metal. - [FDA alerts to Class I recall of BioZorb Marker by Hologic, Inc. due to major risks posed by implanted devices](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-biozorb-marker-by-hologic-inc-due-to-major-risks-posed-by-implanted-devices/): On May 22, 2024, the FDA released a communication warning consumers that Hologic, Inc.'s recall of its BioZorb Marker has been identified as Class I, the most serious type, because use of the product may lead to major injuries or death. - [FDA warns – Palmer Candy recalls white coated confectionary items sold by United Supermarkets due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-palmer-candy-recalls-white-coated-confectionary-items-sold-by-united-supermarkets-due-to-potential-trace-of-salmonella/): United Supermarkets, of Lubbock, Texas, is warning consumers in Texas and New Mexico that white coated confectionary items have been voluntarily recalled by its supplier Palmer Candy because the products may be contaminated with Salmonella. - [FDA alerts to Class I recall of Perseus A500 Anesthesia System due to potential for sudden shutdowns on battery power](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-perseus-a500-anesthesia-system-due-to-potential-for-sudden-shutdowns-on-battery-power/): According to the FDA, Draeger, Inc.'s March 10, 2024, recall of its Perseus A500 Anesthesia System has been identified as identified as Class I, the most serious type, because officials have determined that use of the devices put patients at risk for major injuries or death. - [FDA warns – Single batch of 32oz Aldi Deli Macaroni Salad recalled by Reser’s Fine Foods due to mislabeling, undeclared wheat](https://trulaw.com/fda/fda-warns-single-batch-of-32oz-aldi-deli-macaroni-salad-recalled-by-resers-fine-foods-due-to-mislabeling-undeclared-wheat/): According to the FDA, Aldi Deli Macaroni Salad, 32 oz, under use-by date June 3, 2024, has been recalled by Reser's Fine Foods because of incorrect labeling, which fails to declare wheat as an allergen in the product. - [FDA alerts to Class I recall of specific Route 92 Medical catheter products due to risk of major injuries, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-specific-route-92-medical-catheter-products-due-to-risk-of-major-injuries-death/): According to the FDA, Route 92 Medical Inc. has recalled three lots of its Tenzing 7 Delivery Catheter products after receiving multiple reports of "distal tip separation at the proximal marker band." - [FDA warns – Natural Sourcing International recalls single lot of 32oz Great Value Organic Black Chia Seeds due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-natural-sourcing-international-recalls-single-lot-of-32oz-great-value-organic-black-chia-seeds-due-to-potential-trace-of-salmonella/): According to the FDA, Great Value Organic Black Chia Seeds, in 32-ounce packages, has been voluntarily recalled by Natural Sourcing International because some of the products may be contaminated with the organism Salmonella. - [FDA Warns Patients and Providers of Compatibility Issues with Glatiramer Acetate Autoinjectors](https://trulaw.com/fda/fda-warns-patients-and-providers-of-compatibility-issues-with-glatiramer-acetate-autoinjectors/): The U.S. Food and Drug Administration issued an alert Tuesday warning patients, caregivers, and health care providers about potential cross-compatibility issues with autoinjector devices used to administer glatiramer acetate injection for treating multiple sclerosis. - [FDA Warns: FDA Raises Concerns Over Quality and Safety of Chinese-Manufactured Plastic Syringes](https://trulaw.com/fda/fda-warns-fda-raises-concerns-over-quality-and-safety-of-chinese-manufactured-plastic-syringes/): In a recent announcement, the U.S. Food and Drug Administration (FDA) has expressed growing concerns regarding the quality and performance of plastic syringes manufactured in China. The agency has taken decisive action to protect public health by issuing an import alert for two major China-based manufacturers, Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd., effectively barring their products from entering the United States. - [FDA warns – Goat Milk Formula Recipe Kit recalled by Healthwest Minerals, Inc. dba Mt. Capra Products due to insufficient nutrition as infant formula](https://trulaw.com/fda/fda-warns-goat-milk-formula-recipe-kit-recalled-by-healthwest-minerals-inc-dba-mt-capra-products-due-to-insufficient-nutrition-as-infant-formula/): The Food and Drug Administration (FDA) is advising consumers against using Goat Milk Formula Recipe Kit by Healthwest Minerals, Inc., d/b/a Mt. Capra Products, because the product was found to be insufficient as infant formula. - [FDA warns – MEGA SOFT™ Pediatric Patient Return Electrode discontinued, recalled by MEGADYNE due to risk of burns](https://trulaw.com/fda/fda-warns-mega-soft-pediatric-patient-return-electrode-discontinued-recalled-by-megadyne-due-to-risk-of-burns/): MEGADYNE™, of Cincinnati, Ohio, has announced a discontinuation and voluntary recall of all of its MEGA SOFT™ Pediatric Patient Return Electrodes due to risk of burn injuries, according to the FDA. - [FDA warns – Single lot of Amyloid Complete Product recalled by DaVinci Laboratories due to undeclared shellfish](https://trulaw.com/fda/fda-warns-single-lot-of-amyloid-complete-product-recalled-by-davinci-laboratories-due-to-undeclared-shellfish/): According to the FDA, 72 bottles of Amyloid Complete has been recalled by DaVinci Laboratories, a division of Williston, Vermont-based FoodScience, LLC, because of the potential presence of undeclared shellfish (shrimp and crab). - [FDA warns – Texas Pecan Company nuts, snack mixes, seeds, snack sticks recalled due to multiple undeclared allergens](https://trulaw.com/fda/fda-warns-texas-pecan-company-nuts-snack-mixes-seeds-snack-sticks-recalled-due-to-multiple-undeclared-allergens/): According to the FDA, Dallas, Texas-based Texas Pecan has recalled a variety of its 1-pound and 8-ounce products because they may contain one or more of the following allergens: "tree nuts, peanuts, almonds, brazils, cashews, filberts, macadamias, pistachios, pecans, pine nuts," and walnuts, as well as "soy, dairy (milk), sesame and wheat." - [FDA alerts to Class I recall of VITEK 2 AST Kit by BioMérieux Inc. due to high Ceftriazone concentrations](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-vitek-2-ast-kit-by-biomerieux-inc-due-to-high-ceftriazone-concentrations/): The FDA is warning consumers that the VITEK 2 AST kit, developed for antimicrobial sensitivity testing, has been recalled by BioMérieux Inc. because it was found to contain above-approved concentrations of Ceftriaxone. - [FDA warns – Limited number of 4oz Planters® Honey Roasted Peanuts, 8.75oz Planters® Deluxe Lightly Salted Mixed Nuts due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-limited-number-of-4oz-planters-honey-roasted-peanuts-8-75oz-planters-deluxe-lightly-salted-mixed-nuts-due-to-potential-trace-of-listeria/): Hormel Food Sales, LLC, of Austin, Minnesota, has recalled a number of its 4-ounce packages of Planters® Honey Roasted Peanuts and its 8.75-ounce cans of Planters® Deluxe Lightly Salted Mixed Nuts because the products may be contaminated with Listeria monocytogenes, reports the FDA. - [FDA alerts to Class I recall of Stay-Safe Catheter Extension Sets, Stay-Safe/Luer Lock Adapter due to potentially unsafe levels of NDL-PCBA](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-stay-safe-catheter-extension-sets-stay-safe-luer-lock-adapter-due-to-potentially-unsafe-levels-of-ndl-pcba/): The FDA is warning consumers that Fresenius Medical Care has recalled its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter because use of the products were found to put patients at risk of exposure to high levels of the toxic compound NDL-PCBA. - [FDA warns – Single lot of .39-oz/11-g Potato Chip Mini Chocolate Bar recalled due to undeclared hazelnut](https://trulaw.com/fda/fda-warns-single-lot-of-39-oz-11-g-potato-chip-mini-chocolate-bar-recalled-due-to-undeclared-hazelnut/): A single production lot (Lot 4022) of .39-ounce/11-gram Potato Chip Mini Chocolate Bar has been recalled by Chuao Chocolatier the products are believed to contain hazelnut, an allergen not listed on the packaging's ingredient panel. - [FDA warns – 2.5-ounce packages of Infinite Herbs fresh organic basil recalled due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-2-5-ounce-packages-of-infinite-herbs-fresh-organic-basil-recalled-due-to-potential-trace-of-salmonella/): Miami, Florida-based Infinite Herbs LLC has recalled 2.5-ounce packages of Infinite Herbs-branded fresh organic basil bearing UPC 8 18042 02147 7 and that were made available for purchase between February 1 and April 6, 2024 because of a potential Salmonella contamination. - [FDA alerts to Class I recall of Nimbus, Nimbus II Infusion Pump Systems due to multiple potential failure modes](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-nimbus-nimbus-ii-infusion-pump-systems-due-to-multiple-potential-failure-modes/): According to the FDA, InfuTronix LLC has recalled the Nimbus Administration Set, Flex, and PainPro (also known as the Halo Ambulatory Infusion System), in addition to the Nimbus II PainPRO, Flex, Plus, EpiD, and EMS infusion pumps, due to several potential modes of product failure. Because any of these failures may result in severe injury or death, the recall has been labeled Class I, the most serious type. - [FDA warns – Gibson Farms voluntarily recalls organic walnuts due to possible E. coli contamination](https://trulaw.com/fda/fda-warns-gibson-farms-voluntarily-recalls-organic-walnuts-due-to-possible-e-coli-contamination/): Gibson Farms of Hollister, California said it has recalled its Organic Light Halves and Pieces shelled walnuts after receiving information that the products may have the potential to be contaminated with E. Coli 0157:H7, according to the FDA. - [FDA warns – 24 oz containers of “Queso de Mano PAISA” recalled due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-24-oz-containers-of-queso-de-mano-paisa-recalled-due-to-potential-listeria-contamination/): According to the FDA, Doral, Florida-based Tama Corporation has recalled its "Queso de Mano PAISA," in 24-ounce containers, because the product may contain traces of the bacterium Listeria monocytogenes. - [FDA warns – H-E-B 12-count packages of Creamy Creations Ice Cream in 3 oz. cups recalled due to potential metal](https://trulaw.com/fda/fda-warns-h-e-b-12-count-packages-of-creamy-creations-ice-cream-in-3-oz-cups-recalled-due-to-potential-metal/): According to the FDA, H-E-B has voluntarily recalled 12-count packages of its 3-ounce cup of Creamy Creations ice cream in three different flavors because the products may contain traces of metal. The now-recalled products were distributed and made available for purchase at H-E-B stores across Texas and Mexico, as well as at Central Market, Joe V's Smart Shop, and Mi Tienda stores. - [FDA warns – 2,060 cases of 750mL Primal Kitchen Avocado Oil recalled due to bottle fragility](https://trulaw.com/fda/fda-warns-2060-cases-of-750ml-primal-kitchen-avocado-oil-recalled-due-to-bottle-fragility/): Consumers are advised that about 2,060 cases of Primal Kitchen Avocado Oil (750mL) under three code dates have been recalled by Primal Kitchen because the glass bottles they are packaged in were found likely to break and cause a spill. - [FDA warns – Melissa’s brand fresh organic basil in 2.0 oz, 4.0 oz packages included in Infinite Herbs LLC recall](https://trulaw.com/fda/fda-warns-melissas-brand-fresh-organic-basil-in-2-0-oz-4-0-oz-packages-included-in-infinite-herbs-llc-recall/): Consumers are advised that Melissa's brand fresh organic basil in 2.0-ounce and 4.0-ounce packages are now included in a April 19, 2024 recall initiated by Miami, Florida-based Infinite Herbs LLC. - [FDA alerts to Class I recall of Ivenix Infusion Pump LVP Software due to anomalies, potential for major patient harm and death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-ivenix-infusion-pump-lvp-software-due-to-anomalies-potential-for-major-patient-harm-and-death/): Fresenius Kabi USA, LLC has announced a corrective Class I recall of an infusion pump software, LVP Software, that runs on the Ivenix Infusion System (IIS). Initiated by the firm on March 7, 2024, the action comes after multiple software anomalies were identified and found to pose a risk of serious patient harm or death. - [FDA warns – 20 oz packages of King Kullen Broccoli Cutlets with Bread Crumbs and Parmesan recalled](https://trulaw.com/fda/fda-warns-20-oz-packages-of-king-kullen-broccoli-cutlets-with-bread-crumbs-and-parmesan-recalled/): According to the FDA, 20-ounce packages of "King Kullen Broccoli Cutlets with Bread Crumbs and Parmesan" have been recalled by New Haven, Connecticut-based Gracie's Kitchen due to the potential presence of undeclared sesame and wheat. - [FDA alerts to Class I recall of Obsidio Comformable Embolic by Boston Scientific due to risk of serious injuries, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-obsidio-comformable-embolic-by-boston-scientific-due-to-risk-of-serious-injuries-death/): The FDA is warning consumers of a Class I recall of Boston Scientific's Obsidio Comformable Embolic because the device has been shown to present a risk for increased bowel ischemia when used for lower GI (gastrointestinal) bleeding, or acute colonic bleeding. - [FDA warns – Nutrena Country Feeds Meatbird 22% Crumble recalled by Cargill due to lack of Vitamin D](https://trulaw.com/fda/fda-warns-nutrena-country-feeds-meatbird-22-crumble-recalled-by-cargill-due-to-lack-of-vitamin-d/): Animal nutrition business Cargill has announced a recall of Nutrena Country Feeds Meat bird 22% Crumble (RV) because the product after the product was found to be missing Vitamin D, according to the FDA. - [FDA warns – 20 oz loaves of Roly Poly multigrain bread recalled due to undeclared egg](https://trulaw.com/fda/fda-warns-20-oz-loaves-of-roly-poly-multigrain-bread-recalled-due-to-undeclared-egg/): According to the FDA, New Britain, Connecticut-based Roly Poly Bakery has recalled all of its 20-ounce loaves of Roly Poly multigrain bread because of the presence of undeclared egg. - [FDA alerts to Class I recall of HeartMate II, HeartMate 3 Left Ventricular Assist System (LVAS) due to buildup, potential obstruction](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-heartmate-ii-heartmate-3-left-ventricular-assist-system-lvas-due-to-buildup-potential-obstruction/): The FDA is calling to attention a corrective recall of HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) by Abbott/Thoratec Corp. because long-term buildup in product components may cause an obstruction. Because this blockage could result in serious injuries or death, an FDA announcement released April 15, 2024 has identified the recall as Class I, the most serious type. - [FDA warns – Feel Good Foods recalls Gluten-Free Cream Cheese Stuffed Mini Bagels in Plain, Everything flavors due to undeclared gluten](https://trulaw.com/fda/fda-warns-feel-good-foods-recalls-gluten-free-cream-cheese-stuffed-mini-bagels-in-plain-everything-flavors-due-to-undeclared-gluten/): Consumers are advised that Feel Good Foods, of New York, New York, has recalled its Gluten-Free Cream Cheese Stuffed Mini Bagels in the Plain and Everything flavors due to the potential presence of undeclared gluten from cross-contamination. - [FDA warns – Ice Cream Sandwiches, Gelato produced by Belgian Yummies contains multiple undeclared allergens](https://trulaw.com/fda/fda-warns-ice-cream-sandwiches-gelato-produced-by-belgian-yummies-contains-multiple-undeclared-allergens/): Consumers are advised that multiple undeclared allergens have been identified in the 4-ounce packages of ice cream sandwiches as well as the 5-liter containers and 4.75-liter pans of gelato produced by Belgian Yummies, of Fort Myers, Florida. - [FDA warns – Kowalski Simply Sides Jack’s Potato Salad recalled due to mislabeling, undeclared egg](https://trulaw.com/fda/fda-warns-kowalski-simply-sides-jacks-potato-salad-recalled-due-to-mislabeling-undeclared-egg/): Hamtramck, Michigan-based Home Style Foods, Inc. has recalled 43 cases of its "Kowalski Simply Sides - Jack's Potato Salad" because the product label does not list egg as an allergen on its ingredient panel. - [FDA warns – Aruba Aloe Balm N.V. recalls 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80%, Aruba Aloe Alcoholada Gel due to methanol content](https://trulaw.com/fda/fda-warns-aruba-aloe-balm-n-v-recalls-40-lots-of-aruba-aloe-hand-sanitizer-gel-alcohol-80-aruba-aloe-alcoholada-gel-due-to-methanol-content/): Aruba Aloe Balm N.V., of Oranjestad, Aruba, has recalled 40 lots of its Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel because of the presence of alcohol that has been denatured with methanol, reports the FDA. - [FDA warns – Johnny’s 5oz Parmesan Garlic Seasoning recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-johnnys-5oz-parmesan-garlic-seasoning-recalled-due-to-undeclared-sesame/): Portland, Oregon-based Oregon Spice Company has recalled Johnny's Parmesan Garlic Seasoning in 5-ounce plastic bottles because of the potential presence of undeclared sesame, according to the FDA. - [FDA warns – 708 units of Blues Hog Sweet and Savory Seasoning recalled by Baron Spices, Inc. due to undeclared soy, wheat](https://trulaw.com/fda/fda-warns-708-units-of-blues-hog-sweet-and-savory-seasoning-recalled-by-baron-spices-inc-due-to-undeclared-soy-wheat/): According to the FDA, St. Louis, Missouri-based Baron Spices, Inc. has recalled 708 units of its Blues Hog Sweet and Savory Seasoning due to the potential presence of two undeclared allergens: soy and wheat. - [FDA alerts to Class I recall of Cerenovus CEREBASE DA Guide Sheath due to fractures in distal catheter shaft](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-cerenovus-cerebase-da-guide-sheath-due-to-fractures-in-distal-catheter-shaft/): The FDA is warning healthcare professionals and prospective patients that a February 2, 2024, recall of Cerenovus CEREBASE DA Guide Sheath has been labeled Class I, the most serious type, because use of the product may result in major injuries or death. - [FDA warns – Abdallah 8 oz. Sea Salt Almond Alligators recalled due to mislabeling, undeclared almond](https://trulaw.com/fda/fda-warns-abdallah-8-oz-sea-salt-almond-alligators-recalled-due-to-mislabeling-undeclared-almond/): According to the FDA, Apple Valley, Minnesota-based Abdallah Candies has recalled a production lot (under code 0315) of its 8-ounce Sea Salt Almond Alligators because its packaging bears an incorrect ingredient label that does not list almond as an allergen. - [FDA warns – Deluxe Macarons Party Edition recalled by Lidl due to multiple undeclared allergens](https://trulaw.com/fda/fda-warns-deluxe-macarons-party-edition-recalled-by-lidl-due-to-multiple-undeclared-allergens/): Lidl US, of Arlington, Virginia, has recalled its Deluxe-branded Macarons Party Edition because the products, which bear non-English ingredient labels, were found to contain a number of undeclared allergens: wheat, soy, egg, milk, and three types of tree nuts (almonds, pistachios, and coconut). - [FDA warns – AVpak Atovaquone Oral Suspension, USP 750 mg/5 mL recalled due to potential trace of Bacillus Cereus](https://trulaw.com/fda/fda-warns-avpak-atovaquone-oral-suspension-usp-750-mg-5-ml-recalled-due-to-potential-trace-of-bacillus-cereus/): A single lot (#AW0221A) of Atovaquone Oral Suspension, USP 750mg/5ML, under the AVpak brand, has been recalled by AvKARE, LLC because the product may be contaminated with Bacillus cereus, reports the FDA. - [FDA warns – Helados Mexico Mini Cream Variety Pack recalled by Tropicale Foods due to risk of Salmonella contamination](https://trulaw.com/fda/fda-warns-helados-mexico-mini-cream-variety-pack-recalled-by-tropicale-foods-due-to-risk-of-salmonella-contamination/): 5,224 units of Helados Mexico Mini Cream Variety Pack under best-by date 10/11/2025 has been recalled by Tropicale Foods, of Modesto, California, because the pack's mango bars may contain traces of Salmonella, reports the FDA. - [FDA warns – EZnoble Sushi for Geisslers Supermarket Inc. sushi products recalled due to multiple undeclared allergens](https://trulaw.com/fda/fda-warns-eznoble-sushi-for-geisslers-supermarket-inc-sushi-products-recalled-due-to-multiple-undeclared-allergens/): Due to the potential presence of three undeclared allergens, East Windsor, Connecticut-based Geisslers Supermarket Inc. has recalled all of its EZnoble Sushi-produced sushi products made available for purchase on 3/26/2024 and 3/27/2024 and with corresponding sell-by dates of 3/27/2024 and 3/28/2024. - [FDA warns – 5lb. Food Club All Purpose Flour recalled by Shawnee Milling Company due to undeclared milk, egg](https://trulaw.com/fda/fda-warns-5lb-food-club-all-purpose-flour-recalled-by-shawnee-milling-company-due-to-undeclared-milk-egg/): According to the FDA, Shawnee, Oklahoma-based Shawnee Milling Company has recalled its 5-pound Food Club-branded All Purpose Flour, under "Best if Used by" date 03/07/2025 due to the potential presence of undeclared milk and egg. - [FDA alerts to Class I recall of Instructions for Use for Impella Left Sided Blood Pumps due to risk of injury, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-instructions-for-use-for-impella-left-sided-blood-pumps-due-to-risk-of-injury-death/): According to the FDA, Abiomed has recalled the Instructions for Use for its Impella Left Sided Blood Pumps, in six (6) different types, out of concern that the pump catheter may puncture the wall of the heart's left ventricle, particularly during operations. - [FDA alerts to update in medical device correction of Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes](https://trulaw.com/fda/fda-alerts-to-update-in-medical-device-correction-of-mega-soft-universal-and-universal-plus-reusable-patient-return-electrodes/): A Class I Medical Device Correction (MDC) sent to hospitals on December 8, 2023, regarding the intended use of Megadyne's Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes was revised by Megadyne on February 29, 2024, according to the FDA. - [FDA warns – El Chilar Ground Cinnamon “Canela Molida” recalled due to possible elevated lead levels](https://trulaw.com/fda/fda-warns-el-chilar-ground-cinnamon-canela-molida-recalled-due-to-possible-elevated-lead-levels/): Apopka, Florida-based El Chilar Rodriguez LLC has voluntarily recalled 127 cases (12 1.25-ounce bags/case) of its El Chilar Ground Cinnamon "Canela Molida" because the product may contain traces of lead at elevated levels, according to the FDA. - [FDA warns – Single lot of Treprostinil Injection recalled by Par Pharmaceutical due to potential trace of foreign matter](https://trulaw.com/fda/fda-warns-single-lot-of-treprostinil-injection-recalled-by-par-pharmaceutical-due-to-potential-trace-of-foreign-matter/): Par Pharmaceutical, Inc. (Par), one of the operating companies of Endo International, announced has recalled one lot of its 20 mg/20mL (1mg/mL) Treprostinil Injection because the product solution may contain silicone particulates, according to the FDA. - [FDA warns – La Fiesta Ground Cinnamon recalled due to potential lead contamination](https://trulaw.com/fda/fda-warns-la-fiesta-ground-cinnamon-recalled-due-to-potential-lead-contamination/): La Mirada, California-based La Fiesta Food Products has recalled its .87-ounce Cinnamon Ground because the product may contain a lead contaminant, according to the FDA. - [FDA alerts to Class I recall of AirLife Manual Resuscitators due to risk of injury, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-airlife-manual-resuscitators-due-to-risk-of-injury-death/): According to the FDA, Vyaire Medical, Inc. has recalled nine (9) AirLife Adult Manual Resuscitators because the products were found to have a manufacturing defect that poses a risk of serious injuries or death to its users. - [FDA warns – Single lot of Door County Love Dark Chocolate Cherry Granola recalled due to undeclared almonds](https://trulaw.com/fda/fda-warns-single-lot-of-door-county-love-dark-chocolate-cherry-granola-recalled-due-to-undeclared-almonds/): Ellison Bay, Wisconsin-based Kick Ash Products has recalled a single lot (#061241) of its Door County Love Dark Chocolate Cherry Granola because the product contains almonds, a major allergen not declared in the ingredient list on its label, reports the FDA. - [FDA warns – Trader Joe’s Nuts 50% Less Sodium Roasted & Salted Whole Cashews recalled due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-trader-joes-nuts-50-less-sodium-roasted-salted-whole-cashews-recalled-due-to-potential-trace-of-salmonella/): According to the FDA, a number of production lots of Trader Joe's Nuts - 50% Less Sodium Roasted & Salted Whole Cashews - has been recalled by Wenders LLC, of Dublin, California, due to concerns of a possible Salmonella contamination. - [FDA alerts to Abbott’s Class I recall of HeartMate Touch Communication System](https://trulaw.com/fda/fda-alerts-to-abbotts-class-i-recall-of-heartmate-touch-communication-system/): Patients and healthcare providers are advised of a Class I recall of Abbott's HeartMate Touch System (version 1.0.32) due to the potential for unexpected stops and starts in its pump, which could lead to serious injuries or death, according to the FDA. - [FDA warns – Great Value Honey Roasted Cashews 8.25 oz recalled due to undeclared milk, coconut](https://trulaw.com/fda/fda-warns-great-value-honey-roasted-cashews-8-25-oz-recalled-due-to-undeclared-milk-coconut/): John B. Sanfilippo & Son, Inc (JBSS), of Elgin, Illinois, has recalled a limited quantity of its 8.25-ounce Great Value Honey Roasted Cashews because the product may contain traces of coconut and milk, two major allergens that do not appear on its ingredient list. - [FDA warns – LQNN, Inc. recalls Saigon Gourmet Banh Ba Xa, varieties of Banh Pia due to undeclared egg](https://trulaw.com/fda/fda-warns-lqnn-inc-recalls-saigon-gourmet-banh-ba-xa-varieties-of-banh-pia-due-to-undeclared-egg/): Garden Grove, California-based LQNN, Inc., has recalled its Banh Ba Xa and several varieties of its Banh Pia, under multiple lot numbers and best-by dates, due to the potential presence of egg, an ingredient not declared on the product label. - [FDA warns – 750 units of Wesco Mint No Bake Cookie Bites recalled due to undeclared peanut](https://trulaw.com/fda/fda-warns-750-units-of-wesco-mint-no-bake-cookie-bites-recalled-due-to-undeclared-peanut/): Muskegon, Michigan-based Wesco, Inc. has recalled 750 units of its Wesco Mint No Bake Cookie Bites because it may contain traces of peanut, a major allergen not listed in the product's ingredient list, according to the FDA. - [FDA provides guidance on safe use of electrical operating tables](https://trulaw.com/fda/fda-provides-guidance-on-safe-use-of-electrical-operating-tables/): Following reports of adverse events linked to electrical operating room tables, the U.S. Food and Drug Administration (FDA) is emphasizing user training and advising healthcare providers to carefully follow instructions in the manufacturer's product manual to mitigate risks to patients. - [FDA warns – Avanos Medical, Inc. recalls certain lots of MIC Gastric – Jejunal Feeding Tube Kits after Nurse Assist, LLC recall](https://trulaw.com/fda/fda-warns-avanos-medical-inc-recalls-certain-lots-of-mic-gastric-jejunal-feeding-tube-kits-after-nurse-assist-llc-recall/): On February 21, 2024, Avanos Medical, Inc., of Alpharetta, Georgia, announced a voluntary recall of certain lots of its MIC Gastric - Jejunal Feeding Tube Kits following Nurse Assist, LLC's own voluntary recall of pre-filled syringes, among other sterile water products. - [FDA warns – “SWAD Brand Cinnamon Powder” in 3.5oz Retail Packs recalled due to potential lead contamination](https://trulaw.com/fda/fda-warns-swad-brand-cinnamon-powder-in-3-5oz-retail-packs-recalled-due-to-potential-lead-contamination/): According to the FDA, Skokie, Illinois-based Raja Foods LLC has recalled its 3.5-ounce packages of "SWAD Cinnamon Powder" after learning that the product could contain traces of lead. - [FDA warns – Chillimami Sauce recalled by Aji Mori Sauce Corp., dba Sushi Koo, due to risk of Clostridium botulinum](https://trulaw.com/fda/fda-warns-chillimami-sauce-recalled-by-aji-mori-sauce-corp-dba-sushi-koo-due-to-risk-of-clostridium-botulinum/): Los Angeles, California-based Aji Mori Sauce Corp., doing business as Sushi Koo, has voluntarily recalled its Chillimami Sauce because it was not produced and distributed under the oversight of the California Department of Public Health (CDPH) Cannery Program. As such, FDA officials say that the product is more likely to be contaminated with the microbe Clostridium botulinum. - [FDA warns – KALO Single Slice Carrot Cake recalled due to mislabeling, undeclared soy](https://trulaw.com/fda/fda-warns-kalo-single-slice-carrot-cake-recalled-due-to-mislabeling-undeclared-soy/): Consumers should be advised that Stokesdale, North Carolina-based KALO Foods, LLC has recalled its Single Slice Carrot Cake (under Universal Product Code 8 53407 00418 4) because the product has been found to contain soy, an allergen not listed in the label's ingredient panel. - [FDA alerts to Class I recall of Care Plus, Care Plus Models 1000-4000 and Lullaby Incubators due to risk of major injuries, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-care-plus-care-plus-models-1000-4000-and-lullaby-incubators-due-to-risk-of-major-injuries-death/): The FDA is warning consumers that a corrective recall of Wipro GE Healthcare Private Ltd. Care Plus and Lullaby Incubators has been identified as Class I, the most serious type, because use of the devices has been found to pose a risk of serious injuries or death. - [FDA warns – Nearly 280 bottles of Alipotec Raiz de Tejocote Dietary Supplements with “Alipotec King” sticker recalled due to toxic yellow oleander](https://trulaw.com/fda/fda-warns-nearly-280-bottles-of-alipotec-raiz-de-tejocote-dietary-supplements-with-alipotec-king-sticker-recalled-due-to-toxic-yellow-oleander/): According to the FDA, Los Angeles, California-based Backstage Center has recalled about 280 bottles of Alipotec Raiz de Tejocote dietary supplements bearing the "Alipotec King" sticker after an FDA analysis revealed the product was positive for yellow oleander, a known toxin. - [FDA warns – 1,644 Red Velvet Milk Chocolate Bars recalled by Electric City Sweets due to undeclared milk](https://trulaw.com/fda/fda-warns-1644-red-velvet-milk-chocolate-bars-recalled-by-electric-city-sweets-due-to-undeclared-milk/): Scranton, Pennsylvania-based Electric City Sweets has recalled 1,644 Red Velvet Milk Chocolate Bars because the product label fails to declare the presence of milk in the ingredient and allergen statement. - [FDA warns – Roland® Tahini (100% Ground Sesame Seeds), 16 oz. recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-roland-tahini-100-ground-sesame-seeds-16-oz-recalled-due-to-potential-salmonella-contamination/): New York, New York-based Roland Foods, LLC ("Roland Foods") has recalled one production code of its 16-ounce Roland® Tahini (100% Ground Sesame Seeds) because the product may contain a trace of Salmonella, reports the FDA. - [FDA warns – H&Natural TejoRoot, H&Natural Brazil Seed Dietary Supplements recalled due to presence of poisonous plant](https://trulaw.com/fda/fda-warns-hnatural-tejoroot-hnatural-brazil-seed-dietary-supplements-recalled-due-to-presence-of-poisonous-plant/): According to the FDA, two lots of H&Natural TejoRoot and H&Natural Brazil Seed Dietary Supplements in 10g pills, as well as two lots of H&Natural Brazil Seed in .167g seeds, have been voluntarily recalled by San Luis, Arizona-based G.A. Mart dba H&Natural. - [FDA warns – Single lot of Nordic Naturals Baby’s Vitamin D3 Liquid recalled due to super potent dose of Vitamin D3](https://trulaw.com/fda/fda-warns-single-lot-of-nordic-naturals-babys-vitamin-d3-liquid-recalled-due-to-super-potent-dose-of-vitamin-d3/): Nordic Naturals, of Watsonville, California, has voluntarily recalled a single lot of its Nordic Naturals Baby's Vitamin D3 Liquid in 0.76 fluid ounces (22.5 ML), 400 IU (10mcg) D3, according to the FDA. Officials say a manufacturing error in products under lot number 234909 and expiration date December 2025 has given way to an "elevated level of Vitamin D3 dosage or super potent dose." - [FDA warns – 4 torta sandwiches with cotija cheese recalled by Fresh and Ready Foods due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-4-torta-sandwiches-with-cotija-cheese-recalled-by-fresh-and-ready-foods-due-to-potential-trace-of-listeria/): Fresh & Ready Foods, of San Fernando, California, has recalled four of its torta sandwiches, which contain cotija cheese and which were sold across four states, - [FDA warns – Ready-to-eat Enchiladas recalled by Rico Brand due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-ready-to-eat-enchiladas-recalled-by-rico-brand-due-to-potential-trace-of-listeria/): Salt Lake City, Utah-based Rico Brand has voluntarily recalled four (4) varieties of its Ready-to-eat Enchiladas, which contains cheese, following a voluntary recall announced by Rizo-Lopez Foods, Inc. over concerns of a possible Listeria monocytogenes contamination. - [FDA warns – Wegmans Harissa Hummus Topped with Harissa recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-wegmans-harissa-hummus-topped-with-harissa-recalled-due-to-undeclared-sesame/): Summer Fresh Salads Inc., which operates out of Woodbridge, Ontario, Canada, announced on February 3, 2024, that it is recalling Wegmans Harissa Hummus Topped with Harissa due to the presence of undeclared sesame. - [FDA alerts to Class I recall of High Frequency Transport Phasitron Breathing Circuit Kits due to risk of serious injuries, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-high-frequency-transport-phasitron-breathing-circuit-kits-due-to-risk-of-serious-injuries-death/): The FDA is warning consumers and healthcare professionals that Percussionaire's December 12, 2023 recall of its High Frequency Transport Phasitron Breathing Circuit Kits has been listed as Class I, the most serious type, because use of the product may lead to major injuries or death. - [FDA warns – Zingerman’s Bakehouse recalls packages of Black Magic Brownie due to undeclared walnut](https://trulaw.com/fda/fda-warns-zingermans-bakehouse-recalls-packages-of-black-magic-brownie-due-to-undeclared-walnut/): Ann Arbor, Michigan-based Zingerman's Bakehouse has recalled its individually-packaged and 4-pack packages of Zingerman's Bakehouse Black Magic Brownie because there is reason to believe the product may contain walnuts, a major allergen not declared on the ingredient statement. - [FDA warns – Mexican Style Street Corn Bite Containing Cotija Cheese recalled due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-mexican-style-street-corn-bite-containing-cotija-cheese-recalled-due-to-potential-trace-of-listeria/): According to the FDA, Mexican Style Street Corn Bites, which contains Cotija cheese, has been voluntarily recalled by The Perfect Bite Co., of Glendale, California, because the product may be contaminated by the microbe Listeria Monocytogenes. - [FDA warns – 1 lot of 365 Whole Foods Market Vegan Ultimate Veggie Thin Crust Pizza recalled due to potential presence of milk](https://trulaw.com/fda/fda-warns-1-lot-of-365-whole-foods-market-vegan-ultimate-veggie-thin-crust-pizza-recalled-due-to-potential-presence-of-milk/): A single lot of 365 Whole Foods Markey Vegan Ultimate Veggie Thin Crust Pizza has been recalled by Richelieu Foods Inc. due to potential traces of milk, an allergen not listed in the product's ingredient statement, reports the FDA. - [FDA alerts to Class I recall of Regard Operative Lap P&S Surgical Kit due to risk of of major injuries, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-regard-operative-lap-ps-surgical-kit-due-to-risk-of-of-major-injuries-death/): The FDA is warning healthcare providers and consumers about a December 18, 2023 recall of Regard Operative Lap P&S Surgical Kit by ROi CPS, LLC because the product may not be sterile. Officials have since identified the corrective recall as Class I, the most serious type, because use of the kit was determined to put individuals at risk of "serious injuries or death." - [FDA warns – Multiple dairy products recalled by Rizo-López Foods, Inc. due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-multiple-dairy-products-recalled-by-rizo-lopez-foods-inc-due-to-potential-listeria-contamination/): Rizo-López Foods, Inc. ("RLF"), of Modesto, California, has voluntarily recalled a variety of dairy products under multiple brands because they may contain traces of the organism Listeria monocytogenes. - [FDA warns – Pints of “Tomato Basil with Rice” recalled by Heart Acquisitions Inc. due to undeclared soy](https://trulaw.com/fda/fda-warns-pints-of-tomato-basil-with-rice-recalled-by-heart-acquisitions-inc-due-to-undeclared-soy/): According to the FDA, Brooklyn, New York-based Hearty Acquisitions Inc. has recalled its "Tomato Basil with Rice" in 16oz containers because they were found to actually contain Butternut Squash Bisque, which features soy, an allergen not declared on the product label. - [FDA alerts to Class I recall of ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture due to risk of serious injury, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-excelsiusgps-flat-panel-fluoroscopy-registration-fixture-due-to-risk-of-serious-injury-death/): According to the FDA, a December 7, 2023 recall of Globus Medical, Inc.'s ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture has been identified as Class I, the most serious type, because use of the device may lead to major injuries or death. - [FDA warns – Mighty Fine Chocolate Ice Cream half gallons recalled by Byrne Dairy due to undeclared peanuts](https://trulaw.com/fda/fda-warns-mighty-fine-chocolate-ice-cream-half-gallons-recalled-by-byrne-dairy-due-to-undeclared-peanuts/): According to the FDA, Syracuse, New York-based Byrne Dairy, Inc. has recalled its half-gallon cartons of Byrne Dairy Mighty Fine Chocolate Ice Cream under "Last Date of Sale" 10/4/2024 due to the potential presence of peanuts, an allergen not declared in the ingredient statement. - [FDA warns – Golden Owl Dried Mango recalled by Truong Giang Distributor Corp due to undeclared sulfites](https://trulaw.com/fda/fda-warns-golden-owl-dried-mango-recalled-by-truong-giang-distributor-corp-due-to-undeclared-sulfites/): Philadelphia, Pennsylvania-based Truong Giang Distributor Corp has recalled its Golden Owl Dried Mango due to the potential presence of undeclared sulfites, according to the FDA. - [FDA alerts to Class I recall of AirFit, AirTouch CPAP Masks with Magnets by ResMed Ltd. due to potential magnetic interference](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-airfit-airtouch-cpap-masks-with-magnets-by-resmed-ltd-due-to-potential-magnetic-interference/): According to the FDA, ResMed Ltd. has issued a Class I recall of its AirFit and AirTouch Continuous Positive Airway Pressure (CPAP) masks with magnets because the products may magnetically interfere with other medical devices. - [FDA warns – 8 lots of Robitussin Honey CF Max Day Adult, Nighttime Adult recalled due to microbial contamination](https://trulaw.com/fda/fda-warns-8-lots-of-robitussin-honey-cf-max-day-adult-nighttime-adult-recalled-due-to-microbial-contamination/): Haleon, headquartered in Warren, New Jersey, has voluntarily recalled eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult because the products were found to be contaminated with a microbe, reports the FDA. - [FDA warns – “Lian Sheng Dried Tangerine Plum” recalled by Rong Shing Trading NY Inc. due to undeclared sulfites](https://trulaw.com/fda/fda-warns-lian-sheng-dried-tangerine-plum-recalled-by-rong-shing-trading-ny-inc-due-to-undeclared-sulfites/): Brooklyn, New York-based Rong Shing Trading NY Inc. has recalled all packages of its 4.7oz (135g) "Lian Sheng Dried Tangerine Plum" after learning that the product contains sulfites, an allergen not declared in its ingredient statement. - [FDA warns – Neptune’s Fix Elixir, Extra Strength Elixir, Tablets recalled due to presence of tianeptine](https://trulaw.com/fda/fda-warns-neptunes-fix-elixir-extra-strength-elixir-tablets-recalled-due-to-presence-of-tianeptine/): According to the FDA, Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets have all been recalled by Neptune Resources, LLC because the products contain tianeptine. - [FDA warns – Whitley’s Peanut Factory recalls 12oz Deluxe Nut Mix due to multiple undeclared allergens](https://trulaw.com/fda/fda-warns-whitleys-peanut-factory-recalls-12oz-deluxe-nut-mix-due-to-multiple-undeclared-allergens/): According to the FDA, Hayes, Virginia-based Whitley's Peanut Factory has recalled its 12oz Deluxe Nut Mix under certain code dates due to the potential presence of five allergens (peanuts, milk, soy, wheat, and sesame) which are not declared on the product's ingredient statement. - [FDA warns – Various packages of “Asafoetida” Vandevi Yellow powder recalled due to potential undeclared wheat](https://trulaw.com/fda/fda-warns-various-packages-of-asafoetida-vandevi-yellow-powder-recalled-due-to-potential-undeclared-wheat/): Kinjin Food Pvt. Ltd., of Maharashtra, India, has recalled its "Asafoetida" Vandevi Yellow powder in 50 gm, 100 gm, 200 gm, 500 gm, and 1 kg packages because the product could be contain traces of wheat, an allergen not listed in the product's ingredient list. - [FDA warns – Rizo Bros California Creamery Aged Cotija Mexican Grating Cheese recalled due to potential trace of Listeria](https://trulaw.com/fda/fda-warns-rizo-bros-california-creamery-aged-cotija-mexican-grating-cheese-recalled-due-to-potential-trace-of-listeria/): Modesto, California-based Rizo Lopez Foods, Inc. announced a recall on January 11, 2024, that covers 344 cases of its Aged Cotija Mexican Grating Cheese (8oz) over concerns that the product may be contaminated with Listeria monocytogenes. - [FDA warns – Al Amir Fresh Foods hummus dip products and Tzatziki Cucumber Yogurt recalled due to undeclared sesame, milk](https://trulaw.com/fda/fda-warns-al-amir-fresh-foods-hummus-dip-products-and-tzatziki-cucumber-yogurt-recalled-due-to-undeclared-sesame-milk/): Milwaukie, Oregon-based Al Amir Fresh Foods has recalled its Al Amir-branded hummus dip products and its Tzatziki Cucumber Yogurt due to undeclared sesame and milk, respectively. - [FDA alerts to Class I recall of Mega Soft Universal Patient Return Electrode due to risk of serious injury, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-mega-soft-universal-patient-return-electrode-due-to-risk-of-serious-injury-death/): According to the FDA, a December 8, 2023 recall of Mega Soft Universal Patient Return Electrode by Megadyne Medical Products, Inc. has been identified as Class I, the most serious type. Consumers and healthcare professionals are warned that use of the affected devices could lead to major injuries or death. - [FDA warns – Spinach and Salad Kits recalled by BrightFarms due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-spinach-and-salad-kits-recalled-by-brightfarms-due-to-potential-listeria-contamination/): BrightFarms has voluntarily recalled a limited number of four different salad kit products from its Selinsgrove, Pennsylvania facility due to concerns that they might contain traces of Listeria monocytogenes. The action comes after its supplier, Element Farms, of Pompton Plains, New Jersey, was found to be potentially contaminated with the organism. - [FDA warns – Hans Kissle recalls 7oz Mexican Style Quinoa Salad due to undeclared egg, soy](https://trulaw.com/fda/fda-warns-hans-kissle-recalls-7oz-mexican-style-quinoa-salad-due-to-undeclared-egg-soy/): Haverhill, Massachusetts-based company Hans Kissle has recalled its 7-ounce packages of Mexican Style Quinoa Salad due to the presence of egg and soy, two allergens not declared on the the product's ingredient statement. - [FDA warns – 5 varieties of Benny T’s Vesta Dry Hot Sauces recalled due to undeclared wheat](https://trulaw.com/fda/fda-warns-5-varieties-of-benny-ts-vesta-dry-hot-sauces-recalled-due-to-undeclared-wheat/): Due to undeclared wheat in the product, Vesta Fiery Gourmet Foods, Inc., based in Raleigh, North Carolina, has voluntarily recalled its 1.5oz glass jars of Benny T's Vesta Dry Hot Sauce in five varieties: Vesta Ghost, Vesta Hot, Vesta Reaper, Vesta Scorpio, and Vesta Vary Hot. - [FDA warns against use of Synovo Total Hip Resurfacing System due to unapproved modifications](https://trulaw.com/fda/fda-warns-against-use-of-synovo-total-hip-resurfacing-system-due-to-unapproved-modifications/): Due to a significant modifications to the Synovo Total Hip Resurfacing System, including resurfacing implants, by Synovo Production, Inc., the FDA is advising healthcare providers against use of the device. The agency's January 3, 2024 announcement also outlines recommendations for patients who may have already received specific implants that were part of included in the Synovo Total Hip System after 2019, when three components of the system were altered. - [FDA warns – 1 batch of Big Island Candies Makana Brownie Assortment Box recalled due to undeclared peanuts](https://trulaw.com/fda/fda-warns-1-batch-of-big-island-candies-makana-brownie-assortment-box-recalled-due-to-undeclared-peanuts/): Hilo, Hawaii-based Big Island Candies has voluntarily recalled 120 boxes of its Makana Brownie Assortment Box, under batch 60, due to the presence of peanuts, an allergen not declared on the product's packaging, according to the FDA. - [FDA warns – Tasty Snacks “Plum Queen” Dried Plums recalled due to undeclared sulfites](https://trulaw.com/fda/fda-warns-tasty-snacks-plum-queen-dried-plums-recalled-due-to-undeclared-sulfites/): According to the FDA, Bayonne, New Yersey-based Win Luck Trading, Inc. has recalled its "Plum Queen" Dried Plums because the product label's ingredient panel does not list sulfites as an allergen. - [FDA alerts to Class I recall of Panorama 1.0T HFO due to risk of serious injury or death during quench procedure](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-panorama-1-0t-hfo-due-to-risk-of-serious-injury-or-death-during-quench-procedure/): The FDA is warning consumers that the Panorama 1.0T HFO, initially recalled by Philips North America LLC on November 20, 2023, has since been labeled Class I, the most serious type of recall, due to risk of serious injury or death. - [FDA warns – Melissa’s Kimchi Hot 14 oz recalled by World Variety Produce, Inc. due to undeclared fish](https://trulaw.com/fda/fda-warns-melissas-kimchi-hot-14-oz-recalled-by-world-variety-produce-inc-due-to-undeclared-fish/): Los Angeles, California-based World Variety Produce, Inc. has recalled Melissa's Kimchi Hot 14 oz because it contains fish, an allergen not listed on the product's ingredient panel. - [FDA warns – Herold’s Salads Inc. recalls assorted deli salads due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-herolds-salads-inc-recalls-assorted-deli-salads-due-to-potential-listeria-contamination/): Herold's Salads Inc., of Cleveland, Ohio, has recalled 28 varieties of packaged deli salads under multiple brand names because the products may contain a trace of Listeria monocytogenes, reports the FDA. - [FDA warns – Chocew Burnt Caramel Candy Bars recalled due to undeclared coconut](https://trulaw.com/fda/fda-warns-chocew-burnt-caramel-candy-bars-recalled-due-to-undeclared-coconut/): According to the FDA, Lakewood, New Jersey-based Astor Chocolate Corporation has voluntarily recalled 1,092 Burnt Caramel Candy Bars because they may contain undeclared coconut. - [FDA warns – 1 lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial recalled due to potential trace of glass particulate matter](https://trulaw.com/fda/fda-warns-1-lot-of-bleomycin-for-injection-usp-15-units-single-dose-onco-tain-glass-fliptop-vial-recalled-due-to-potential-foreign-matter/): According to the FDA, Pfizer company Hospira, Inc. has voluntarily recalled a single lot (lot BL12206A) of its Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial because the product may contain glass particulate matter. - [FDA warns – Nature’s Wonder Mung Bean Sprouts recalled by Chang Farm due to Listeria contamination](https://trulaw.com/fda/fda-warns-natures-wonder-mung-bean-sprouts-recalled-by-chang-farm-due-to-listeria-contamination/): According to the FDA, Wheatley, Massachusetts-based Chang Farm has recalled its 12-ounce packages of Nature's Wonder Mung Bean Sprouts, under sell-by date December 13, 2023, because it contains a trace of Listeria monocytogenes (L. Monocytogenes). - [FDA warns – Multiple varieties of ToYou Snacks Snack Bars recalled due to undeclared soy](https://trulaw.com/fda/fda-warns-multiple-varieties-of-toyou-snacks-snack-bars-recalled-due-to-undeclared-soy/): Winter Garden, Florida-based ToYou Snacks has recalled its ToYou-branded snack bars in multiple flavors (Coconut Mocha, Chocolate Mango, Salted Caramel Dark Chocolate, Mint Dark Chocolate, Banana Foster, Mango Yogurt) due to the presence of soy, an allergen not declared on the product's ingredient statement, reports the FDA. - [FDA warns – Various lots of Medline Tracheostomy Care and Cleaning Trays recalled due to potential defect](https://trulaw.com/fda/fda-warns-various-lots-of-medline-tracheostomy-care-and-cleaning-trays-recalled-due-to-potential-defect/): Consumers and healthcare providers are advised that Medline Industries, LP. has voluntarily recalled multiple lots and SKUs of its Tracheostomy Care and Cleaning Trays because of a number of potential component defects. - [FDA warns – Wine Country Gift Baskets with Quaker Chewy Granola Bars recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-wine-country-gift-baskets-with-quaker-chewy-granola-bars-recalled-due-to-potential-salmonella-contamination/): Fullerton, California-based Houdini, Inc. has voluntarily recalled all of its Wine Country Gift Baskets containing Quaker Chewy Granola Bars because the granola bars may be contaminated with the Salmonella organism. The precautionary measure follows Quaker Oats' own recent recall of the product. - [FDA warns – Eban’s Bakehouse recalls 12-count packages of Sweet Indulgences cookie bites due to undeclared milk, soy](https://trulaw.com/fda/fda-warns-ebans-bakehouse-recalls-12-count-packages-of-sweet-indulgences-cookie-bites-due-to-undeclared-milk-soy/): According to the FDA, Eban's Bakehouse has voluntarily recalled its 12-count, 11.85-ounce boxes of Sweet Indulgences cookie bites because the products contain milk and soy, two allergens not declared on the ingredient label. - [FDA alerts to recall of saline and sterile water medical products manufactured by Nurse Assist, LLC](https://trulaw.com/fda/fda-alerts-to-recall-of-saline-and-sterile-water-medical-products-manufactured-by-nurse-assist-llc/): Consumers, healthcare providers and healthcare facilities are advised against use of certain recalled saline (0.9% sodium chloride) and sterile water medical products, sold under various brands, which have been recalled by the manufacturer, Nurse Assist, LLC, reports the FDA. - [FDA warns – 8-ounce Fresh Express Spinach, 9-ounce Publix Spinach recalled due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-8-ounce-fresh-express-spinach-9-ounce-publix-spinach-recalled-due-to-potential-listeria-contamination/): According to the FDA, Fresh Express has voluntarily recalled a number of its Fresh Express Spinach, 8-ounce size, along with a number of Publix Spinach, 9-ounce size, because the products may contain a trace of Listeria monocytogenes. - [FDA warns – Americaine® 20% Benzocaine Topical Anesthetic Spray recalled due to trace of benzene](https://trulaw.com/fda/fda-warns-americaine-20-benzocaine-topical-anesthetic-spray-recalled-due-to-trace-of-benzene/): The FDA is alerting consumers to a nationwide recall of Americaine® 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals, a company under Prestige Consumer Healthcare Inc., due to the unexpected presence of benzene in the product. - [FDA warns – 5-pound packages of Aviator-branded Dehydrated Tomato Halves due to undeclared sulfites](https://trulaw.com/fda/fda-warns-5-pound-packages-of-aviator-branded-dehydrated-tomato-halves-due-to-undeclared-sulfites/): According to the FDA, Global Veg Corp, headquartered in New York, New York, has recalled its 5-pound packages of Aviator-branded Dehydrated Tomato Halves, under all lots and codes, due to the potential presence of undeclared sulfites. - [FDA warns – Philips DreamStation 2 CPAP machines at risk of overheating](https://trulaw.com/fda/fda-warns-philips-dreamstation-2-cpap-machines-at-risk-of-overheating/): Patients and healthcare providers are advised that they should closely monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for potential overheating, according to a November 28, 2023 U.S. Food and Drug Administration announcement. - [FDA warns – Shakespeare’s Pizza recalls all frozen pizzas due to undeclared wheat](https://trulaw.com/fda/fda-warns-shakespeares-pizza-recalls-all-frozen-pizzas-due-to-undeclared-wheat/): According to the FDA, Columbia, Missouri-based Shakespeare's Pizza has recalled all varieties of its frozen pizzas, sold in grocery stores, due to the undeclared presence of wheat. - [FDA warns – Himalayan Pain Relief Tea recalled by WS Global, Inc. due to undeclared drugs](https://trulaw.com/fda/fda-warns-himalayan-pain-relief-tea-recalled-by-ws-global-inc-due-to-undeclared-drugs/): Brooklyn, New York-based WS Global, Inc. has announced a nationwide voluntary recall of its Himalayan Pain Relief Tea tea packets due to the undeclared presence of the drugs Diclofenac and Dexamethasone, reports the FDA. - [FDA warns – Batch of private-label Holiday Nog sold in United Dairy Farmers stores recalled due to undeclared egg](https://trulaw.com/fda/fda-warns-batch-of-private-label-holiday-nog-sold-in-united-dairy-farmers-stores-recalled-due-to-undeclared-egg/): Prairie Farms, Dairy, Inc. has announced a voluntary recall that covers a certain batch of its private-label Holiday Nog, made available in United Dairy Farmers stores from December 4th to December 6th, 2023, due to potential undeclared egg, reports the FDA. - [FDA alerts to potential failures of plastic syringes manufactured in China](https://trulaw.com/fda/fda-alerts-to-potential-failures-of-plastic-syringes-manufactured-in-china/): Following an analysis of collected data, the FDA is warning consumers and healthcare providers of possible device failures (including leaks and breakages) in plastic syringes manufactured in China. - [FDA warns – Bobo’s Peach Oat Bars recalled due to mis-packaging, undeclared coconut](https://trulaw.com/fda/fda-warns-bobos-peach-oat-bars-recalled-due-to-mis-packaging-undeclared-coconut/): According to the FDA, Loveland, Colorado-based Bobo's has voluntarily a number of its Bobo's Peach Oat Bars due to the potential presence of coconut, an allergen not listed in the product's ingredient list. - [FDA warns – Single lot of Manischewitz Dark Chocolate Coins recalled due to mislabeling, undeclared milk](https://trulaw.com/fda/fda-warns-single-lot-of-manischewitz-dark-chocolate-coins-recalled-due-to-mislabeling-undeclared-milk/): According to the FDA, Manischewitz, of Bayonne, New Jersey, has voluntarily recalled a single lot of its Manischewitz Dark Chocolate Coins due to the potential presence of milk, an allergen not declared on product labeling. - [FDA alerts to Class I recall of Sapphire Infusion Pumps due to software issues, failure to detect air in the line](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-sapphire-infusion-pumps-due-to-software-issues-failure-to-detect-air-in-the-line/): According to the FDA, Eitan Medical Ltd's September 11, 2023 recall of its Sapphire Infusion Pumps, running on software version Rev 16.10, has been upgraded to Class I because use of the product could result in major injuries or death. - [FDA warns – Pan de Racho, Panque, Tres Leches, Chocoflan, Pan Surtido recalled by Lara’s Bakery 3 LLC due to undeclared allergens](https://trulaw.com/fda/fda-warns-pan-de-racho-panque-tres-leches-chocoflan-pan-surtido-recalled-by-laras-bakery-3-llc-due-to-undeclared-allergens/): Marshalltown, Iowa-based Lara's Bakery 3 LLC has recalled multiple products, including Pan de Racho, Panque, and Pan Surtido in various flavors, due to the presence of undeclared sesame seed, coconut, soy, wheat, milk, and egg. - [FDA alerts to major risk of T-cell malignancy in BCMA-directed or CD19-directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies](https://trulaw.com/fda/fda-alerts-to-major-risk-of-t-cell-malignancy-in-bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies/): The FDA is informing the public of reports it has received indicating T-cell malignancies, which include chimeric antigen receptor CAR-positive lymphoma, in patients who were treated with autologous CAR T cell immunotherapies under BCMA (B-cell maturation antigen) or CD19 direction. - [FDA warns – Fresh-cut cantaloupe products recalled by GHGA, LLC and Sofia Produce due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-fresh-cut-cantaloupe-products-recalled-by-ghga-llc-and-sofia-produce-due-to-potential-trace-of-salmonella/): GHGA, LLC has voluntarily recalled select fresh-cut cantaloupe products derived from whole fruits supplied by Sofia Produce, LLC (dba TruFresh), which were themselves recently recalled due to the potential presence of Salmonella, according to the FDA. - [FDA warns – 3,600 packets of Maggi 2-Minute Noodles in 280g, 560g recalled due to undeclared peanut](https://trulaw.com/fda/fda-warns-3600-packets-of-maggi-2-minute-noodles-in-280g-560g-recalled-due-to-undeclared-peanut/): Milpitas, California-based New India Bazar has recalled 2,400 packets of Maggi 2-Minute Noodles, 280g, and 1,200 packets of Maggie 2-Minute Noodles, 560g, due to the potential presence of peanut, a major allergen not listed on the product's ingredient list. - [FDA warns – 3 lots of Burn Boot Camp Afterburn Grass-fed Whey Protein Bars, 60g recalled due to potential foreign material](https://trulaw.com/fda/fda-warns-3-lots-of-burn-boot-camp-afterburn-grass-fed-whey-protein-bars-60g-recalled-due-to-potential-foreign-material/): According to the FDA, Doctors Scientific Organica, of Riviera Beach, Florida, has voluntarily recalled three lots of its Burn Boot Camp Afterburn Grass-fed Whey Protein Bars (60 grams) in Triple Chocolate Almond flavor because they may contain traces of foreign material: disposable hairnet, shrink wrap, and parchment paper. - [FDA warns – Varieties of Gaws deli subs, breakfast bagel sandwiches recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-varieties-of-gaws-deli-subs-breakfast-bagel-sandwiches-recalled-due-to-undeclared-sesame/): Marysville, Michigan-based Gaws Gourmet Foods has recalled three varieties of its 8-inch deli subs and two varieties of its breakfast bagel sandwiches due to the potential presence of undeclared sesame, according to the FDA. - [FDA alerts to Class I recall of VariSoft Infusion Sets due to device damage, unexpected disconnections](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-varisoft-infusion-sets-due-to-device-damage-unexpected-disconnections/): The FDA is warning consumers that Unomedical A/S's October 11, 2023 recall of its VariSoft Infusion Sets has been labeled Class I, the most serious type, because use of the device could result in major injuries or death. - [FDA alert – Consumers advised to discard “Hilltop Meadow Farm” brand “60 Day Aged Pepper Jack Raw Milk Cheese” due to potential trace of Listeria](https://trulaw.com/fda/fda-alert-consumers-advised-to-discard-hilltop-meadow-farm-brand-60-day-aged-pepper-jack-raw-milk-cheese-due-to-potential-trace-of-listeria/): According to the FDA, the Pennsylvania Department of Agriculture is warning consumers that certain "Hilltop Meadow Farm"-branded "60 Day Aged Pepper Jack Raw Milk Cheese" should be disposed of due to the potential presence of the bacteria Listeria monocytogenes. - [FDA warns – Whole cantaloupes under “Malichita Z Farms” label recalled due to risk of Salmonella contamination](https://trulaw.com/fda/fda-warns-whole-cantaloupes-under-malichita-z-farms-label-recalled-due-to-risk-of-salmonella-contamination/): Fresno, California-based Jewel Marketing and Agribusiness LLC (dba Crown Jewels Produce) has recalled 1,960 boxes of whole cantaloupes under the Malichita / Z Farms label because they may be contaminated with Salmonella, according to the FDA. - [FDA warns – Sienna Bakery® Chocolate Decadent Brownies recalled by Dianne’s Fine Desserts due to undeclared peanut](https://trulaw.com/fda/fda-warns-sienna-bakery-chocolate-decadent-brownies-recalled-by-diannes-fine-desserts-due-to-undeclared-peanut/): 512 cases (2,048 trays) of Gordon Food Service (GFS) Sienna Bakery® Chocolate Decadent Brownies (GFS#226240) and Sienna Bakery® Chocolate Peanut Butter Brownies have been recalled by Dianne's Fine Desserts due to a mislabeling and undeclared peanut, according to the FDA. - [FDA warns – Novum IQ Syringe Pump recalled by Baxter Healthcare Corporation due to risk of under-dose](https://trulaw.com/fda/fda-warns-novum-iq-syringe-pump-recalled-by-baxter-healthcare-corporation-due-to-risk-of-under-dose/): According to the FDA, Baxter Healthcare Corporation's September 21, 2023 recall of its Novum IQ Syringe Pump is now identified as Class I, the most serious type, because use of the device has been found to put users at risk of serious injuries or death. - [FDA warns – Private-label Egg Custard Pie recalled by Publix Supermarkets, Inc. due to undeclared coconut](https://trulaw.com/fda/fda-warns-private-label-egg-custard-pie-recalled-by-publix-supermarkets-inc-due-to-undeclared-coconut/): Publix Supermarkets, Inc., of Lakeland, Florida, has voluntarily recalled certain batches of private-label Egg Custard Pie sold between October 20, 2023 and November 16, 2023 because they may contain coconut, an allergen not listed on the product's ingredient statement. - [FDA warns – Dr. Ergin’s SugarMD Advanced Glucose Support Supplements recalled due to undeclared glyburide, metformin](https://trulaw.com/fda/fda-warns-dr-ergins-sugarmd-advanced-glucose-support-supplements-recalled-due-to-undeclared-glyburide-metformin/): SugarMDs, LLC, of Maryland Heights, Montana, has voluntarily recalled one lot (Lot 22165-003) of its Advance Glucose Support Supplement in 60-, 120- and 180-count bottles because the product may contain undeclared glyburide and metformin, according to the FDA. - [FDA warns – 400g packages of Eltahan Golden Raisins recalled due to undeclared sulfites](https://trulaw.com/fda/fda-warns-400g-packages-of-eltahan-golden-raisins-recalled-due-to-undeclared-sulfites/): According to the FDA, 400-gram packages of Eltahan Golden Raisins under one best-by date have been recalled by Paterson, New-Jersey-based company USA Hookah, LLC (doing business as Eltahan) due to the potential presence of undeclared sulfites. - [FDA warns – Fresh-cut cantaloupe products recalled by Vinyard Fruit and Vegetable Company due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-fresh-cut-cantaloupe-products-recalled-by-vinyard-fruit-and-vegetable-company-due-to-potential-trace-of-salmonella/): Vinyard Fruit and Vegetable Company, of Oklahoma City, Oklahoma, has voluntarily recalled fresh-cut cantaloupe products under twelve different codes because they may be contaminated with Salmonella, reports the FDA. - [FDA alerts to Class I recall of Olympus High Flow Insufflation Unit due to risk of over-inflation](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-olympus-high-flow-insufflation-unit-due-to-risk-of-over-inflation/): The FDA is warning healthcare providers and consumers that Olympus's August 9, 2023 recall of its Olympus High Flow Insufflation Unit has now been labeled Class I, the most serious type, because use of an uncorrected product could cause serious injuries or death. - [FDA warns – Farm Raised Lightly Seasoned Atlantic Salmon Burgers sold at Whole Foods Market stores recalled due to undeclared sesame, milk](https://trulaw.com/fda/fda-warns-farm-raised-lightly-seasoned-atlantic-salmon-burgers-sold-at-whole-foods-market-stores-recalled-due-to-undeclared-sesame-milk/): Fall River, Massachusetts-based Raw SeaFoods, Inc. has recalled its Farm Raised Lightly Seasoned Atlantic Salmon Burgers, under PLU (price look-up) code 56228 and sell-by date 9/11/23-11/18/23, because of undeclared sesame and milk allergens in the product, according to the FDA. - [FDA warns – Over 16,000 bags of Off The Eaten Path Chickpea Veggie Crisps recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-over-16000-bags-of-off-the-eaten-path-chickpea-veggie-crisps-recalled-due-to-undeclared-milk/): According to the FDA, Frito-Lay has recalled 16,100 bags of its 6 1/4-ounce Off The Eaten Path Chickpea Veggie Crisps because caramel seasoned crisps were misplaced in the packages, resulting in undeclared milk ingredients. - [FDA warns – Certain Rugby Laboratories-branded eye drops from Velocity Pharma, LLC recalled due to risk of eye infections](https://trulaw.com/fda/fda-warns-certain-rugby-laboratories-branded-eye-drops-from-velocity-pharma-llc-recalled-due-to-risk-of-eye-infections/): La Vergne, Tennessee-based The Harvard Group, LLC (also doing business as Major® Pharmaceutical and Rugby® Laboratories) has voluntarily recalled all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) because the products pose a risk of eye infections, according to the FDA. - [FDA warns – 35 lots of Fresh Diced Onions recalled by Gills Onions due to potential trace of Salmonella](https://trulaw.com/fda/fda-warns-35-lots-of-fresh-diced-onions-recalled-by-gills-onions-due-to-potential-trace-of-salmonella/): According to the FDA, Oxnard, California-based Gills Onions has voluntarily recalled select lots of its fresh diced onion products because they may contain traces of Salmonella. - [FDA alerts to Class I recall of V60 and V60 Plus Ventilators by Philips Respironics due to risk of power failure, loss of function](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-v60-and-v60-plus-ventilators-by-philips-respironics-due-to-risk-of-power-failure-loss-of-function/): The FDA is warning consumers that Philips Respironics's August 25, 2023, recall of its V60 and V60 Plus Ventilators has been labeled Class I, the most serious type, because use of the product has been found to pose risks of serious injury or death. - [FDA warns – WanaBana Apple Cinnamon Fruit Purée pouches recalled due to elevated lead levels](https://trulaw.com/fda/fda-warns-wanabana-apple-cinnamon-fruit-puree-pouches-recalled-due-to-elevated-lead-levels/): The FDA is alerting consumers to the voluntary recall of WanaBana Apple Cinnamon Fruit Purée, in 2.5-ounce pouches, because WanaBana USA has received reports of elevated lead levels in a number of the products. - [FDA warns – Kuka Flex Forte, Artri King, Reumo Flex capsules recalled by Botanical-Be due to undeclared Diclofenac](https://trulaw.com/fda/fda-warns-kuka-flex-forte-artri-king-reumo-flex-capsules-recalled-by-botanical-be-due-to-undeclared-diclofenac/): According to the FDA, Botanical-Be has voluntarily recalled all lots of dietary supplements under multiple brands, including Kuka Flex Forte capsules, Artri King capsules, and Reumo Flex capsules, because the products have been found to contain traces of Diclofenac. - [FDA warns – 50lb. bags of Retriever All Life Stages Mini Chunk Chicken Recipe Dry Dog Food recalled due to potential Salmonella contamination](https://trulaw.com/fda/fda-warns-50lb-bags-of-retriever-all-life-stages-mini-chunk-chicken-recipe-dry-dog-food-recalled-due-to-potential-salmonella-contamination/): Nacogdoches, Texas-based Texas Farm Products Company, dba TFP Nutrition, has voluntarily recalled its 50-pound bags of Retriever All Life Stages Mini Chunk Chicken Recipe Dry Dog Food because the product may contain traces of Salmonella, reports the FDA. - [FDA warns – Refrigerated, frozen cooked lobster products recalled by Greenhead Lobster due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-refrigerated-frozen-cooked-lobster-products-recalled-by-greenhead-lobster-due-to-potential-listeria-contamination/): Greenhead Lobster Products LLC, of Bucksport, Maine, has voluntarily recalled all of its frozen and refrigerated cooked lobster meat products, produced between May 9, 2023 and October 19, 2023, because they may contain traces of Listeria monocytogenes. - [FDA warns – Nature’s Path Organic Pumpkin Spice Waffles, Organic Dark Chocolate Chip Waffles recalled due to undeclared peanut](https://trulaw.com/fda/fda-warns-natures-path-organic-pumpkin-spice-waffles-organic-dark-chocolate-chip-waffles-recalled-due-to-undeclared-peanut/): According to the FDA, certain batches of Nature's Path Organic Pumpkin Spice Waffles and Organic Dark Chocolate Chip Waffles have been recalled due to the potential presence of peanuts, an allergen not listed in the product's ingredient list. - [FDA issues update regarding airborne chemicals from GE HealthCare neonatal incubators](https://trulaw.com/fda/fda-issues-update-regarding-airborne-chemicals-from-ge-healthcare-neonatal-incubators/): Following its initial February 23, 2023 announcement and June update informing healthcare providers about potential exposure to airborne chemicals released from GE HealthCare neonatal incubators, the FDA is pointing to new information from the company about how to reduce formaldehyde levels before distribution and use. - [FDA warns – Single run of 16oz bagged Kroger Collard Greens recalled due to potential trace of Listeria monocytogenes](https://trulaw.com/fda/fda-warns-single-run-of-16oz-bagged-kroger-collard-greens-recalled-due-to-potential-trace-of-listeria-monocytogenes/): According to the FDA, Norman Park, Georgia-based Baker Farms has voluntarily recalled one production run of its 16-ounce bagged Kroger Collared Greens because it may be contaminated with Listeria monocytogenes. - [FDA warns – Wegmans Organic Sweet Kale Chopped Salad Kit recalled due to undeclared egg](https://trulaw.com/fda/fda-warns-wegmans-organic-sweet-kale-chopped-salad-kit-recalled-due-to-undeclared-egg/): Soledad, California-based Braga Fresh has voluntarily recalled a single production run of its Wegmans Organic Sweet Kale Chopped Salad Kit because its condiment ingredients contain egg, an allergen not listed on the product label. - [FDA warns – Jay Robb Vanilla Flavored Egg White Protein recalled due to potential presence of foreign material](https://trulaw.com/fda/fda-warns-jay-robb-vanilla-flavored-egg-white-protein-recalled-due-to-potential-presence-of-foreign-material/): According to the FDA, Select Custom Solutions is voluntarily recalling a single lot of 24-ounce Jay Robb Vanilla Flavored Egg White Protein because hard plastic foreign material may be found in the product, posing a choking hazard. - [FDA alerts to Class I recall of HAMILTON-C1, T1, MR-1 Ventilators due to potential capacitator leaks, short circuits](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-hamilton-c1-t1-mr-1-ventilators-due-to-potential-capacitator-leaks-short-circuits/): The FDA has identified Hamilton Medical Inc.'s recall of its HAMILTON-C1, T1, and MR-1 Ventilators as Class I, the most serious type, because potential capacitator leaks and short circuits in the product could cause major injuries or death. - [FDA warns – Stabilyze Dark Chocolate Peanut Butter recalled by Betty Lou’s Inc. due to undeclared sesame](https://trulaw.com/fda/fda-warns-stabilyze-dark-chocolate-peanut-butter-recalled-by-betty-lous-inc-due-to-undeclared-sesame/): According to the FDA, McMinnville, Oregon-based Betty Lou's Inc. has voluntarily recalled Stabilyze Dark Chocolate Peanut Butter, in 1.76-ounce (50 gram) packages and under "Best before" date 05APR24, because the product may contain sesame, an allergen not listed in the ingredient statement. - [FDA warns – Mini Fruit Jelly Cups in assorted flavors recalled by Tiffany Food Corp. due to potential choking hazard](https://trulaw.com/fda/fda-warns-mini-fruit-jelly-cups-in-assorted-flavors-recalled-by-tiffany-food-corp-due-to-potential-choking-hazard/): According to the FDA, Tiffany Food Corp. has recalled its Mini Fruit Jelly Cups, in all codes and flavors, out of concern that the products present a choking hazard. - [FDA warns – Stolen, defective McGRATH MAC video laryngoscopes being sold by unauthorized third parties](https://trulaw.com/fda/fda-warns-stolen-defective-mcgrath-mac-video-laryngoscopes-being-sold-by-unauthorized-third-parties/): According to the FDA, Medtronic is warning consumers that any McGRATH MAC video laryngoscopes being sold by unauthorized third parties via several social media platforms were stolen and are potentially defective. - [FDA warns – Paradise Flavors ice cream bars recalled due to multiple undeclared allergens, color additives](https://trulaw.com/fda/fda-warns-paradise-flavors-ice-cream-bars-recalled-due-to-multiple-undeclared-allergens-color-additives/): Over 40 different flavors of Paradise Flavors ice cream bars has been recalled by Paradise Flavors LLC, of Marathon, Florida, due to the presence of several undeclared allergens in the products, including peanuts, tree nuts (chestnuts, walnuts, hazelnuts, pecans, pine nuts, cashews), wheat, soy, and milk, in addition to a range of undeclared color additives (FD&C blue #1, blue #2, red #3, red #5, red #6, red #40, yellow #5 yellow #6, yellow #8). - [FDA warns – 3 lots of Yarnell’s Guilt Free No Sugar Added Homemade Vanilla Ice Cream recalled due to undeclared egg](https://trulaw.com/fda/fda-warns-3-lots-of-yarnells-guilt-free-no-sugar-added-homemade-vanilla-ice-cream-recalled-due-to-undeclared-egg/): Yarnell Operations LLC, headquartered in Searcy, Arkansas, has voluntarily recalled three lots of Yarnell's Guilt Free No Sugar Added Homemade Vanilla Ice Cream (sold in 48-ounce/1.5-quart containers) due to the potential presence of egg, an allergen not declared on the product's ingredient statement, according to the FDA. - [FDA warns – Single lot of Betaxolol Tablets, USP 10 mg recalled as precaution due to single foreign tablet found on production line post-packaging](https://trulaw.com/fda/fda-warns-single-lot-of-betaxolol-tablets-usp-10-mg-recalled-as-precaution-due-to-single-foreign-tablet-found-on-production-line-post-packaging/): According to the FDA, KVK-Tech, Inc. has recalled a single lot (Batch Number 17853A) of Betaxolol Tablets, USP 10 mg, at the consumer level because a foreign tablet, Oxycodone HCI, 5 mg, was discovered during production line clearance after the batch was packaged. - [FDA warns – Cookies-N-Milk “Chocolate Chip Edible Cookie Dough” recalled due to mis-packaging, undeclared peanuts](https://trulaw.com/fda/fda-warns-cookies-n-milk-chocolate-chip-edible-cookie-dough-recalled-due-to-mis-packaging-undeclared-peanuts/): According to the FDA, McKinney, Texas-based Cookies-N-Milk has recalled 6-ounce cups of product labeled "Chocolate Chip Edible Cookie Dough" because the actual product inside may be Peanut Butter Edible Cookie Dough, which contains peanuts not declared on the packaging. - [FDA warns – all lots of ION* Sinus Support, ION* Sinus, Restore Sinus Spray products recalled due to microbial contamination](https://trulaw.com/fda/fda-warns-all-lots-of-ion-sinus-support-ion-sinus-restore-sinus-spray-products-recalled-due-to-microbial-contamination/): Biomic Sciences, headquartered in Charlottesville, Virginia, has voluntarily recalled all lots of its ION* Sinus Support, ION* Sinus, and Restore Sinus Spray because FDA testing revealed the products to be contaminated with microbes, according to the agency. - [FDA warns – 6-ounce packages of Stewart’s-branded Chocolate Chip Cookies recalled due to undeclared macadamia nuts](https://trulaw.com/fda/fda-warns-6-ounce-packages-of-stewarts-branded-chocolate-chip-cookies-recalled-due-to-undeclared-macadamia-nuts/): According to the FDA, 2,367 6-ounce packages of Chocolate Chip Cookies under the Stewart's brand have been recalled by The Cookie Factory, doing business as Maverick Ventures, LLC, because they contain undeclared macadamia nut. - [FDA alerts to risk of invasive disease in preterm infants given products with live bacteria, yeast](https://trulaw.com/fda/fda-alerts-to-risk-of-invasive-disease-in-preterm-infants-given-products-with-live-bacteria-yeast/): The FDA is warning healthcare providers and consumers that preterm infants given products formulated with live bacteria or yeast (also known as probiotics) are at risk of an invasive, potentially fatal disease. - [FDA warns – Kula Can Piña Colada + Kratom Seltzer recalled due to undeclared coconut, milk](https://trulaw.com/fda/fda-warns-kula-can-pina-colada-kratom-seltzer-recalled-due-to-undeclared-coconut-milk/): According to the FDA, Kula Brands LLC has recalled one lot of its Kula Can - Piña Colada + Kratom Seltzer, packaged in 12-ounce cans, because the product contains tree nuts (coconut) and milk, two allergens not declared on product labeling. - [FDA warns – Family Dollar recalls certain over-the-counter drugs, medical devices due to subpar storage conditions](https://trulaw.com/fda/fda-warns-family-dollar-recalls-certain-over-the-counter-drugs-medical-devices-due-to-subpar-storage-conditions/): According to the FDA, a number of over-the-counter drugs and medical devices regulated by the agency have been voluntarily recalled by Family Dollar because the products were stored outside of the company's labeled temperature requirements. - [FDA warns – Orgain Organic Plant Protein + Superfoods Powder in Creamy Chocolate Fudge recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-orgain-organic-plant-protein-superfoods-powder-in-creamy-chocolate-fudge-recalled-due-to-undeclared-sesame/): A limited-production run of Orgain Organic Protein Powder + Superfoods, Creamy Chocolate Fudge flavor, has been voluntary recalled by Orgain LLC because of the potential presence of sesame, an allergen not listed in the product's ingredient statement. - [FDA alerts to Class I recall of Hamilton-C1, C2, C3, T1 Ventilators due to software issues, unexpected stops](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-hamilton-c1-c2-c3-t1-ventilators-due-to-software-issues-unexpected-stops/): According to the FDA, Hamilton Medical Inc. has recalled four ventilators, including Hamilton-C1, Hamilton-C2, Hamilton-C3, and Hamilton-T1, after receiving reports of software issues that have caused some of the products to stop unexpectedly. Due to the risk of serious injuries or death presented by this issue, the recall has been identified as Class I. - [FDA warns – Dick Taylor Craft Chocolate’s Ginger Snap Milk Chocolate recalled due to undeclared peanuts](https://trulaw.com/fda/fda-warns-dick-taylor-craft-chocolates-ginger-snap-milk-chocolate-recalled-due-to-undeclared-peanuts/): Eureka, California-based Dick Taylor Craft Chocolate has recalled a single batch of "Ginger Snap Milk Chocolate" bars because the wrappers actually contain the brand's Peanut Butter Dark Chocolate, and undeclared peanuts. - [FDA alerts to Class I recall of Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Solution due to non-sterility](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-hudson-rci-addipak-unit-dose-vial-0-9-full-normal-solution-due-to-non-sterility/): According to the FDA, Medline Industries's July 24, 2023 recall of Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, has been labeled Class I after its non-sterility was determined to put users at risk of serious injuries or death. - [FDA warns – 2.2-oz jars of Brady Street Cheese Sprinkle recalled by Penzeys Spices due to undeclared sesame](https://trulaw.com/fda/fda-warns-2-2-oz-jars-of-brady-street-cheese-sprinkle-recalled-by-penzeys-spices-due-to-undeclared-sesame/): Wauwatosa, Wisconsin-based Penzeys Spices has announced a voluntary recall of its Brady Street Cheese Spring, in 2.2-ounce jars and under SKU/Item Number 20756, because of the potential presence of sesame seeds, an allergen not listed on the product's label. - [FDA warns – Sunnyside Farms 32-oz. Diced Organic Butternut Squash recalled due to E. coli O45 scare](https://trulaw.com/fda/fda-warns-sunnyside-farms-32-oz-diced-organic-butternut-squash-recalled-due-to-e-coli-o45-scare/): Vineland, New Jersey-based Safeway Fresh Foods has recalled its 32-ounce package of Diced Organic Butternut Squash, under the Sunnyside Farms brand, because the product may be contaminated with Escherichia coli O45, according to the FDA. - [FDA warns – Single lot of Sucralfate Oral Suspension, 1g/10mL, recalled due to Bacillus Cereus contamination](https://trulaw.com/fda/fda-warns-single-lot-of-sucralfate-oral-suspension-1g-10ml-recalled-due-to-bacillus-cereus-contamination/): VistaPharm LLC, of Largo, Florida, has voluntarily recalled a single lot of its Sucralfate Oral Suspension, 1g/10mL, because the product was found to contain traces of the microbe Bacillus cereus, according to the FDA. - [FDA warns – 24-ounce packages of Cachapas de Maiz Paisa recalled due to undeclared wheat, soy, yellow #5](https://trulaw.com/fda/fda-warns-24-ounce-packages-of-cachapas-de-maiz-paisa-recalled-due-to-undeclared-wheat-soy-yellow-5/): According to the FDA, Doral, Florida-based Tama Corporation has recalled its 24-ounce packages of "Cachapas de Maiz Paisa," sweet corn pancakes, due to the presence of the wheat and soy allergens, as well as Yellow #5--three ingredients not disclosed in the product's ingredient statement. - [FDA alerts to Class I recall of Proclaim and Infinity IPGs due to inability to exit MRI mode](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-proclaim-and-infinity-ipgs-due-to-inability-to-exit-mri-mode/): According to the FDA, Abbott Medical's recall of its Proclaim and Infinity IPGs has been labeled Class I because the product's inability to exit magnetic resonance imaging (MRI) mode in certain circumstances poses risks of serious injury or death to its users. - [FDA warns – 83,800 cases of Kraft Singles American processed cheese slices recalled due to packaging defect](https://trulaw.com/fda/fda-warns-83800-cases-of-kraft-singles-american-processed-cheese-slices-recalled-due-to-packaging-defect/): According to the FDA, about 83,800 cases of individually-wrapped Kraft Singles American processed cheese slices have been voluntarily recalled by Kraft Heinz because of a potential choking hazard caused by a packaging defect. - [FDA warns – Marketside Chocolate Chip Explosion Cake recalled by David’s Cookies due to mislabeling, undeclared peanuts](https://trulaw.com/fda/fda-warns-marketside-chocolate-chip-explosion-cake-recalled-by-davids-cookies-due-to-mislabeling-undeclared-peanuts/): According to the FDA, 960 units of "Marketside Chocolate Chip Explosion Cake" under lot number BS23212, sold at Walmart retail stores nationwide, have been recalled by David's Cookies due to a mislabeling. - [FDA warns – Bone Matrix Product may be linked to recent tuberculosis (TB) outbreak](https://trulaw.com/fda/fda-warns-bone-matrix-product-may-be-linked-to-recent-tuberculosis-tb-outbreak/): The FDA is alerting patients and healthcare professionals of a likely connection between a bone matrix product, also known as a human cell and tissue-based product (HCT/P), and recent reports of a Mycobacterium tuberculosis (Mtb) outbreak in the United States. - [FDA warns – Knickerbocker Homestyle Hamburger Buns recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-knickerbocker-homestyle-hamburger-buns-recalled-due-to-undeclared-milk/): Madison Heights, Michigan-based Knickerbocker 365, Inc. has recalled eight lots of its 16-ounce packages of "Homestyle Hamburger Buns" after being alerted that the ingredient statement for the product, which contains milk, does not list the allergen. - [FDA alerts to Class I recall of One-Way Valve, 22F x 22M by Mallinckrodt due to product malfunction](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-one-way-valve-22f-x-22m-by-mallinckrodt-due-to-product-malfunction/): A nationwide recall of the One-Way Valve, 22F x 22M, part of the INOmax Delivery System by Mallinckrodt Manufacturing, LLC, has been identified by the FDA as Class I, the most serious type, because use of the device may lead to a major injury or death. - [FDA warns – Varieties of mooncake gift boxes recalled by Sheng Kee of California, Inc. due to undeclared egg](https://trulaw.com/fda/fda-warns-varieties-of-mooncake-gift-boxes-recalled-by-sheng-kee-of-california-inc-due-to-undeclared-egg/): According to the FDA, as many as ten varieties of Sheng Kee of California Mooncake Gift Boxes is being covered by a voluntary recall announced by the company on September 11, 2023, due to the potential presence of egg, an allergen not declared on packaging. - [FDA warns – Novartis recalls one lot of Sandimmune® Oral Solution, 100 mg/mL due to crystal formation](https://trulaw.com/fda/fda-warns-novartis-recalls-one-lot-of-sandimmune-oral-solution-100-mg-ml-due-to-crystal-formation/): The FDA is alerting consumers to a voluntary, nationwide recall of a single lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL by Novartis because of crystallization. Officials say that crystal formation had been discovered in a number of the bottles under the recalled lot, prompting concerns about potential incorrect dosing. - [FDA warns – Multiple Life Raft Treats ice cream products recalled because of Listeria monocytogenes scare](https://trulaw.com/fda/fda-warns-multiple-life-raft-treats-ice-cream-products-recalled-because-of-listeria-monocytogenes-scare/): According to the FDA, Life Raft Treats has recalled three ice cream products, including its 64-ounce bucket of Not Fried Chicken, 2.5-ounce Not Fried Chicken bar (UPC 8 60006 18210 6), and 6-count box of Life Is Peachy, because the products may contain traces of the organism Listeria monocytogenes. - [FDA warns – Single lot of TheraBreath Strawberry Splash for Kids, 16oz recalled due to microbial contamination](https://trulaw.com/fda/fda-warns-single-lot-of-therabreath-strawberry-splash-for-kids-16oz-recalled-due-to-microbial-contamination/): Church & Dwight Co., of Ewing, New Jersey, has announced a voluntary recall of one lot of its 16-ounce TheraBreath Strawberry Splash for Kids because that specific lot was found to be contaminated with yeast (Candida Parapsilosis), according to the FDA. - [FDA warns – Single lot of Victor Super Premium Dog Food, Hi-Pro Plus recalled due to risk of Salmonella contamination](https://trulaw.com/fda/fda-warns-single-lot-of-victor-super-premium-dog-food-hi-pro-plus-recalled-due-to-risk-of-salmonella-contamination/): Mount Pleasant, Texas-based Mid America Pet Food has voluntarily recalled a single lot of Victor Super Premium Dog Food, Hi-Pro Plus because the product may potentially contain traces of Salmonella, according to the FDA. - [FDA warns – Weis Quality Brownie Moose Tracks Ice Cream, 48oz recalled due to undeclared egg](https://trulaw.com/fda/fda-warns-weis-quality-brownie-moose-tracks-ice-cream-48oz-recalled-due-to-undeclared-egg/): Weis Market Inc., a Mid-Atlantic food retailer based in Sunbury, Pennsylvania, has recalled its 48-ounce containers of Weis Quality Brownie Moose Tracks Ice Cream because the product may contain traces of egg, an allergen not declared on the ingredient statement label, according to the FDA. - [FDA warns – Single lot of Digoxin Tablets USP in 0.125mg, 0.25mg recalled due to swapped labels](https://trulaw.com/fda/fda-warns-single-lot-of-digoxin-tablets-usp-in-0-125mg-0-25mg-recalled-due-to-swapped-labels/): Marlex Pharmaceuticals, Inc., of New Castle, Delaware, has announced a voluntary, consumer-level recall of one lot of Digoxin Tablets USP, 0125mg, as well as one lot of Digoxin Tablets USP, 0.25mg, because the labels of both products have been mixed up, according to the FDA. - [FDA UPDATE: O&M Halyard recalls single lot of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, Model 46827 due to risk of protection failure](https://trulaw.com/fda/fda-update-om-halyard-recalls-single-lot-of-fluidshield-surgical-n95-respirator-mask-orange-small-level-3-model-46827-due-to-risk-of-protection-failure/): According to the FDA, O&M Halyard has recalled lot #AM2164811 of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, in Model 46827, due to concerns that the respirator may provide insufficient filtration protection to the user. - [FDA warns – Nuez De La India Seeds recalled by Todorganic, Inc. due to potential toxicity](https://trulaw.com/fda/fda-warns-nuez-de-la-india-seeds-recalled-by-todorganic-inc-due-to-potential-toxicity/): Middleburg, Florida-based Todorganic, Inc. has announced a recall of its Nuez de la India Seeds following an FDA analysis that indicates the product may pose a health risk. - [FDA warns – WEFUN Capsules recalled by Hua Da Trading Inc, dba Wefun Inc, due to undeclared sildenafil](https://trulaw.com/fda/fda-warns-wefun-capsules-recalled-by-hua-da-trading-inc-dba-wefun-inc-due-to-undeclared-sildenafil/): Brooklyn, New York-based Hua Da Trading Inc, dba Wefun Inc, has announced a voluntary recall of 300 boxes of its WEFUN Capsules because the product was found to contain traces of sildenafil, an ingredient not disclosed on packaging, reports the FDA. - [FDA warns – Ice Cream House recalls Dairy Ice Cream Products, Non-dairy frozen Dessert products due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-ice-cream-house-recalls-dairy-ice-cream-products-non-dairy-frozen-dessert-products-due-to-potential-listeria-contamination/): On August 30, 2023, Ice Cream House announced a voluntary recall of all Dairy Ice Cream Products and Non-dairy frozen Dessert products because they may contain traces of the organism Listeria monocytogenes, according to the FDA. - [FDA warns – Dr. Berne’s Whole Health Products recalls MSM 5% and 15% Solution Eye Drops, Castor Oil Eye Drops, MSM MIST Drops 5% Solution](https://trulaw.com/fda/fda-warns-dr-bernes-whole-health-products-recalls-msm-5-and-15-solution-eye-drops-castor-oil-eye-drops-msm-mist-drops-5-solution/): According to the FDA, all lots of MSM DROPS, in 5% and 15% Solution, as well as Dr. Berne's Organic Castor Oil Eye Drops and Dr. Berne's MSM MIST 15% Solution, has been voluntarily recalled by Dr. Berne's Whole Health Products due to potential bacterial and fungal contamination. - [FDA warns – Single lot of Texas Tamale Black Bean Tamales recalled due to mislabeling, undeclared milk](https://trulaw.com/fda/fda-warns-single-lot-of-texas-tamale-black-bean-tamales-recalled-due-to-mislabeling-undeclared-milk/): According to the FDA, Texas Tamale Co. has recalled a single lot of its Texas Tamale Black Bean Tamales because the products may contain milk, a major allergen not declared on the packaging's ingredient statement. Officials say the mislabeling is due to Hatch Green Chile and Cheese Tamales being inadvertently packed in bags marked for Black Bean Tamales. - [FDA warns – Inmar Supply Chain Solutions, LLC recalls products under multiple brands due to Salmonella risk, storage conditions](https://trulaw.com/fda/fda-warns-inmar-supply-chain-solutions-llc-recalls-products-under-multiple-brands-due-to-salmonella-risk-storage-conditions/): According to the FDA, several FDA-regulated products under multiple brands have been voluntarily recalled by Inmar Supply Chain Solutions, LLC because of sub-optimal storage conditions at the company's Arlington, Texas facility, where the items were housed. - [FDA warns – McNess 18% Goat Starter feed recalled due to excessive levels of Monovet® 90 (monensin), health risk](https://trulaw.com/fda/fda-warns-mcness-18-goat-starter-feed-recalled-due-to-excessive-levels-of-monovet-90-monensin-health-risk/): Rockford, Illinois-based Furst-McNess Company has recalled its 18% Goat Starter medicated feed, marketed under the McNess brand, because the product has been found to contain a dangerous level of Monovet® 90, a generic form of monensin manufactured by Huvepharma. - [FDA alerts to Class I recall of Impella RP Flex with SmartAssist by Abiomed due to potential blood clots](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-impella-rp-flex-with-smartassist-by-abiomed-due-to-potential-blood-clots/): An FDA announcement posted August 17, 2023, has identified Abiomed's voluntary recall of Impella RP Flex with SmartAssist as Class I, the most serious type, because use of the product under its current Instructions for Use (IFU) may lead to serious injuries or death. - [FDA warns – Frozen Super Sweet Corn and Mixed Vegetables under Food Lion, Kroger, other brands recalled due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-frozen-super-sweet-corn-and-mixed-vegetables-under-food-lion-kroger-other-brands-recalled-due-to-potential-listeria-contamination/): Stanwood, Washington-based Twin City Foods, Inc. has recalled several lots of its Not-Ready-To-Eat Individually Quick Frozen (IQF) Super Sweet Cut Corn and Mixed Vegetables, sold in retail bags, because the products may contain traces of the organism Listeria monocytogenes. - [FDA warns – Limited quantity of Peanut Butter Maltballs recalled by Stonewall Kitchen due to undeclared soy, wheat, peanuts](https://trulaw.com/fda/fda-warns-limited-quantity-of-peanut-butter-maltballs-recalled-by-stonewall-kitchen-due-to-undeclared-soy-wheat-peanuts/): Stonewall Kitchen, a specialty food producer based in York, Maine, has recalled a limited number of its 6-ounce packages of Peanut Butter Maltballs because the products contain soy, wheat, and peanuts--three major allergens not declared on the packaging's ingredient statement. - [FDA alerts to Class I recall of Trilogy Evo, Evo O2, EV300, Evo Universal ventilators due to potential build-up](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-trilogy-evo-evo-o2-ev300-evo-universal-ventilators-due-to-potential-build-up/): The FDA is calling to attention a Class I recall of Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators by Philips Respironics because environmental dust and dirt have been found in the air path of a number of the devices, prompting concerns of blockages. - [FDA warns – Nestlé USA recalls 2 batches of Nestlé Toll House Chocolate Chip Cookie Dough Bars due to possible traces of foreign material](https://trulaw.com/fda/fda-warns-nestle-usa-recalls-2-batches-of-nestle-toll-house-chocolate-chip-cookie-dough-bars-due-to-possible-traces-of-foreign-material/): Arlington, Virginia-based Nestlé USA has voluntarily recalled two batches of its 16.5-ounce Nestlé Toll House Chocolate Chip Cookie Dough "break and bake" Bars because the products may contain fragments of wood, according to the FDA. - [FDA warns against use of 15 tests manufactured by Universal Meditech, Inc. due to company shutdown](https://trulaw.com/fda/fda-warns-against-use-of-15-tests-manufactured-by-universal-meditech-inc-due-to-company-shutdown/): On August 11, 2023, the FDA issued a safety communication warning consumers against the use of 15 tests manufactured by Universal Meditech, Inc. (UMI), which has since ceased all operations and support for the tests. - [FDA warns – select Knorr Sopa Soup Mix products recalled by Unilever US, Inc. due to possible undeclared egg](https://trulaw.com/fda/fda-warns-select-knorr-sopa-soup-mix-products-recalled-by-unilever-us-inc-due-to-possible-undeclared-egg/): Unilever United States, Inc., of Englewood Cliffs, New Jersey, has voluntarily recalled a number of its Knorr Sopa Soup Mix products in three varieties because of the potential presence of egg, an allergen not included on the label's printed ingredient list. - [FDA alerts to updated Class I recall of Cardiosave Hybrid and Rescue IABPs due to sudden shutdowns](https://trulaw.com/fda/fda-alerts-to-updated-class-i-recall-of-cardiosave-hybrid-and-rescue-iabps-due-to-sudden-shutdowns/): Datascope/Maquet/Getinge has released more information regarding a Class I recall of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs), initiated due to unexpected shutdowns, according to the FDA. - [FDA warns – Soft Serve On The Go cups recalled by Real Kosher Ice Cream due to risk of Listeria contamination](https://trulaw.com/fda/fda-warns-soft-serve-on-the-go-cups-recalled-by-real-kosher-ice-cream-due-to-risk-of-listeria-contamination/): According to the FDA, Brooklyn, New York-based Real Kosher Ice Cream has recalled all flavors of its 8-fluid ounce Soft Serve On The Go ice cream and sorbet cups because they may contain traces of the organism Listeria monocytogenes. - [FDA warns – Bickel’s Snack Foods, Inc. recalls 2 lots of Butter Flavored Popcorn due to mislabeling, undeclared milk](https://trulaw.com/fda/fda-warns-bickels-snack-foods-inc-recalls-2-lots-of-butter-flavored-popcorn-due-to-mislabeling-undeclared-milk/): York, Pennsylvania-based Bickel's Snack Foods, Inc. has announced a voluntarily recall of two lots of its 8-ounce Butter Flavored Popcorn because the product contains milk, an allergen not declared on its ingredient statement. - [FDA alerts – Dräger Carina Sub-Acute Care Ventilators recalled due to potential 1,3-Dichloropropan-2-ol contamination in breathing gas](https://trulaw.com/fda/fda-alerts-drager-carina-sub-acute-care-ventilators-recalled-due-to-potential-13-dichloropropan-2-ol-contamination-in-breathing-gas/): According to the FDA, Drägerwerk AG & Co. KGaA has voluntarily recalled its Dräger Carina Sub-Acute Care Ventilators because the breathing gas emitted by the device may be contaminated with 1,3-Dichloropropan-2-ol, a component of the PE-PUR foam installed for sound insulation. - [FDA warns – Zespri Organic Green Kiwifruit recalled by David Oppenheimer and Company I LLC due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-zespri-organic-green-kiwifruit-recalled-by-david-oppenheimer-and-company-i-llc-due-to-potential-listeria-contamination/): David Oppenheimer and Company I, LLC (Oppy), of Vancouver, BC, has announced a voluntary recall of all one-pound clamshells of its organic green kiwifruit because the product may be contaminated with traces of the organism Listeria monocytogenes, according to the FDA. - [FDA warns – limited number of 14.5-ounce and 1-ounce bags of Doritos Nacho Cheese Flavored Tortilla Chips recalled due to undeclared soy, wheat](https://trulaw.com/fda/fda-warns-limited-number-of-14-5-ounce-and-1-ounce-bags-of-doritos-nacho-cheese-flavored-tortilla-chips-recalled-due-to-undeclared-soy-wheat/): Frito-Lay, of Plano, Texas, has voluntarily recalled less than 7,000 bags of its 14.5-ounce and 1-ounce Doritos Nacho Cheese Flavored Tortilla Chips due to the possible presence of soy and wheat ingredients, two major allergens not declared on its ingredient statement. - [FDA alerts to Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in U.S., Puerto Rico](https://trulaw.com/fda/fda-alerts-to-urgent-medical-device-correction-for-spectrum-v8-and-spectrum-iq-infusion-pumps-in-u-s-puerto-rico/): According to the FDA, Baxter International Inc., of Deerfield, Illinois, has announced an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps operating under software versions v8.01.01 and v9.02.01. Devices that have been upgraded to the aforementioned software versions have demonstrated an increased likelihood of producing false upstream occlusion alarms. - [FDA warns – Ozona Organics, LLC recalls 7 lots of liquid probiotic products for humans, animals due to potential health risk](https://trulaw.com/fda/fda-warns-ozona-organics-llc-recalls-7-lots-of-liquid-probiotic-products-for-humans-animals-due-to-potential-health-risk/): Ozona, Texas-based Ozona Organics, LLC has announced a voluntarily recall of up to seven lots of its liquid probiotic products because the water activity in the formula may be conducive to microbial growth, according to the FDA. - [FDA warns – 15 cases of Member’s Mark Breaded Mozzarella Sticks recalled due to undeclared egg, soy](https://trulaw.com/fda/fda-warns-15-cases-of-members-mark-breaded-mozzarella-sticks-recalled-due-to-undeclared-egg-soy/): According to the FDA, Buffalo, New York-based Rich Products has recalled 15 cases of Member's Mark Breaded Mozzarella Sticks because the product may have traces of egg and soy, two major allergens not listed in its ingredient statement. - [FDA warns – 2 lots of Tydemy oral contraceptive tablets recalled due to potentially reduced effectiveness](https://trulaw.com/fda/fda-warns-2-lots-of-tydemy-oral-contraceptive-tablets-recalled-due-to-potentially-reduced-effectiveness/): On July 28, 2023, Lupin Pharmaceuticals Inc., of Baltimore, Maryland, announced that it had voluntarily recalled two lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the consumer level. - [FDA warns – 1400 pounds of Jersey Girl, Toma Celena, Abbie cheese products recalled due to risk of Listeria contamination](https://trulaw.com/fda/fda-warns-1400-pounds-of-jersey-girl-toma-celena-abbie-cheese-products-recalled-due-to-risk-of-listeria-contamination/): Milford, New York-based Coopertown Cheese Company has announced a recall of 1400 pounds of cheese under multiple labels because the products may contain traces of the organism Listeria monocytogenes. - [FDA warns – ONO Vegan Blueberry Muffin Protein Overnight Oats recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-ono-vegan-blueberry-muffin-protein-overnight-oats-recalled-due-to-undeclared-milk/): San Diego, California-based ONO LLC has voluntarily recalled a single lot of its 2.75-ounce packages of ONO Vegan Blueberry Muffin Protein Overnight Oats because the product may contain milk. Not only is milk not listed on the packaging's ingredient statement, inclusion of the allergen directly contradicts the product's vegan claim, which appears prominently at the front of the packaging. - [FDA alerts to Class I recall of TruSignal SpO2 Sensors for risk of reduced defibrillation energy, exposure to unintended voltage, inaccurate readings](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-trusignal-spo2-sensors-for-risk-of-reduced-defibrillation-energy-exposure-to-unintended-voltage-inaccurate-readings/): GE HealthCare's recall of its TruSignal SpO2 sensors has been identified as Class I, the most serious type, because use of the product may lead to serious injuries or death, according to the FDA. - [FDA warns – Cava Spicy Hummus recalled due to mislabeling, undeclared sesame](https://trulaw.com/fda/fda-warns-cava-spicy-hummus-recalled-due-to-mislabeling-undeclared-sesame/): According to the FDA, Cava Foods, Inc. has voluntarily recalled a single lot of its CAVA Spicy Hummus because the product may contain sesame, an allergen not listed on the packaging's ingredient statement. - [FDA alerts to Class I recall of Impella Left Sided Blood Pumps due to inadequate Instructions for Use, potential defect](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-impella-left-sided-blood-pumps-due-to-inadequate-instructions-for-use-potential-defect/): A voluntary recall of all Impella Left Sided Blood Pumps by Abiomed has been labeled Class I, the most serious type, after the FDA determined that use of the product may result in serious injuries or death. - [FDA warns – Outshine No Sugar Added Strawberry Fruit Bars recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-outshine-no-sugar-added-strawberry-fruit-bars-recalled-due-to-undeclared-milk/): According to the FDA, Dreyer's Grand Ice Cream, Inc. has voluntarily recalled two batches of its 6-count packages of Outshine No Sugar Added Strawberry Fruit Bars because the products may contain trace levels of undeclared milk. - [FDA alerts to Class I recall of Abbott Amplatzer Steerable Delivery Sheath due to increased risk of air embolism](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-abbott-amplatzer-steerable-delivery-sheath-due-to-increased-risk-of-air-embolism/): Abbott has announced a Class I recall of its Amplatzer Steerable Delivery Sheath because patients who undergo procedures using this device face an increased risk for air bubbles (air emboli). The FDA identified the recall as Class I, the most serious type, because the device defect could lead to serious injuries or death. - [FDA warns – 12-ounce bags of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit recalled due to undeclared allergens](https://trulaw.com/fda/fda-warns-12-ounce-bags-of-365-by-whole-foods-market-organic-asian-inspired-chopped-salad-kit-recalled-due-to-undeclared-allergens/): According to the FDA, a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit, produced by Braga Fresh, has been voluntarily recalled because the product may contain undeclared milk and egg. - [FDA warns against use of unapproved RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices](https://trulaw.com/fda/fda-warns-against-use-of-unapproved-royalvibe-health-cellquicken-or-well-being-reality-ultrasound-medical-devices/): The FDA is alerting consumers to the dangers of ultrasound medical devices manufactured by RoyalVibe Health, CellQuicken, and Well-Being Reality, all of which have not been reviewed for safety and effectiveness. - [FDA Warns – Heinen’s Fresh Ground Cashew Butter recalled due to undeclared peanuts, almonds](https://trulaw.com/fda/fda-warns-heinens-fresh-ground-cashew-butter-recalled-due-to-undeclared-peanuts-almonds/): Heinen's, based in Warrensville Heights, Ohio, has announced a voluntarily recall of its Heinen's-branded Fresh Ground Cashew Butter because it may contain peanuts or almonds, two allergens not declared in the product's ingredient statement. - [FDA Warns – Packages of Ziyad Brand Jameed Soup Starter recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-packages-of-ziyad-brand-jameed-soup-starter-recalled-due-to-undeclared-milk/): According to the FDA, Ziyad Brothers Importing has recalled its 35.2 fluid ounce packages of Ziyad Brand Jameed Soup Starter because the product's ingredient list does not clearly declare the presence of milk, a major allergen. - [FDA alerts to Class I recall of Quidel Triage Cardiac Panels due to risk of false negative troponin results](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-quidel-triage-cardiac-panels-due-to-risk-of-false-negative-troponin-results/): The FDA is calling to attention a Class I recall of Quidel Triage Cardiac Panels by Quidel Cardiovascular Inc. (QuidelOrtho) because the device may produce false negative troponin results, which could potentially lead to a delayed diagnosis or a missed myocardial infarction. - [FDA Warns – Betty Lou’s Brand Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds recalled due to undeclared sesame](https://trulaw.com/fda/fda-warns-betty-lous-brand-paleo-java-nuts-about-energy-balls-with-cacao-coffee-pumpkin-seeds-recalled-due-to-undeclared-sesame/): Betty Lou's Inc., of McMinnville, Oregon, has announced a voluntary recall of its 1.5-ounce (42g) packages of Betty Lou's Brand Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds because they may contain sesame, an allergen not listed in its ingredient statement. - [FDA alerts to Class I recall of Oxylog 3000 Plus Emergency and Transport Ventilator due to risk of serious injury, death](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-oxylog-3000-plus-emergency-and-transport-ventilator-due-to-risk-of-serious-injury-death/): A recall of Draeger Medical's Oxylog 3000 Plus Emergency and Transport Ventilators has been identified by the FDA as Class I, the most serious type, indicating that use of the products could cause serious injuries or death. - [FDA Warns – Single lot of Spring Valley Potato Blintzes recalled due to undeclared milk](https://trulaw.com/fda/fda-warns-single-lot-of-spring-valley-potato-blintzes-recalled-due-to-undeclared-milk/): On July 6, 2023, Goshen, New York-based MilMar Food Group, LLC announced a recall of a single lot of its Spring Valley Potato Blintzes because the product may contain milk, an allergen not declared on the packaging's ingredient statement. - [FDA alerts to Class I recall of NOxBOXi Nitric Oxide System due to manifold failure, risk of gas leaks, interrupted therapy](https://trulaw.com/fda/fda-alerts-to-class-i-recall-of-noxboxi-nitric-oxide-system-due-to-manifold-failure-risk-of-gas-leaks-interrupted-therapy/): The FDA is calling to attention a Class I recall of NOxBOXi Nitric Oxide System by NOxBOX Ltd. because of a manifold defect that may lead to gas leaks and interrupted therapy to neonates. - [FDA Warns – Select packages of Van’s Gluten Free Original Waffles recalled due to undeclared wheat](https://trulaw.com/fda/fda-warns-select-packages-of-vans-gluten-free-original-waffles-recalled-due-to-undeclared-wheat/): Van's International Foods, of Oakbrook Terrace, Illinois, has voluntarily recalled limited packages of Van's Gluten Free Original Waffles because the product may contain wheat. Not only is the allergen not declared on the product's ingredient statement, the potential presence of wheat contradicts the packaging's "gluten free" claim. - [FDA Warns – 2 varieties of belVita Breakfast Sandwich products recalled due to undeclared peanut](https://trulaw.com/fda/fda-warns-2-varieties-of-belvita-breakfast-sandwich-products-recalled-due-to-undeclared-peanut/): Mondelēz Global LLC, of East Hanover, New Jersey, has voluntarily recalled two varieties of its belVita Breakfast Sandwich because the products may contain traces of peanut, an allergen not declared on the packaging's ingredient statement. - [FDA Alerts – Class I recall of MEGA 2000, MEGA Soft Reusable Patient Return Electrodes due to serious injury risk](https://trulaw.com/fda/fda-alerts-class-i-recall-of-mega-2000-mega-soft-reusable-patient-return-electrodes-due-to-serious-injury-risk/): The FDA is calling to attention a Class I recall of Megadyne's MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes, which have been found to be capable of causing serious burn injuries. - [FDA Warns – Fry Daddy’s Party Mix products recalled due to mislabeling, undeclared walnuts](https://trulaw.com/fda/fda-warns-fry-daddys-party-mix-products-recalled-due-to-mislabeling-undeclared-walnuts/): Fry Daddy's Brand, of Walker, Michigan, has voluntarily recalled its Party Mix products, in all flavors and sizes, because the finished products contain walnuts, an allergen not declared on the packaging's ingredient statement. - [FDA Updates – Single lot of Tome Corse Sheep Ottavi cheese recalled due to risk of Listeria monocytogenes contamination](https://trulaw.com/fda/fda-updates-single-lot-of-tome-corse-sheep-ottavi-cheese-recalled-due-to-risk-of-listeria-monocytogenes-contamination/): Cumming, Georgia-based Estancia Holdings is the latest company whose products are impacted by a Listeria monocytogenes scare following an outbreak in Europe, according to the FDA. - [FDA Alerts – 6 batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg recalled by Cipla due to defect](https://trulaw.com/fda/fda-alerts-6-batches-of-albuterol-sulfate-inhalation-aerosol-90-mcg-recalled-by-cipla-due-to-defect/): Cipla US, a wholly-owned subsidiary of Cipla Limited, of Mumbai, India and New Jersey, USA, has voluntarily recalled six batches of its Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) because of a defect in the product's container. - [FDA Updates – Pamana Brand Mini Fruit Jelly Cup recalled by Foremost Foods Corporation due to choking hazard](https://trulaw.com/fda/fda-updates-pamana-brand-mini-fruit-jelly-cup-recalled-by-foremost-foods-corporation-due-to-choking-hazard/): Foremost Food Corporation's Pamana Brand Mini Fruit Jelly Cup (35.27 oz.) is the latest fruit jelly snack to be voluntarily recalled because the size of an individual jelly cup poses a choking risk, according to the FDA. - [FDA Warns – Cadia and Trader Joe’s Organic Pineapple recalled due to possible Listeria monocytogenes contamination](https://trulaw.com/fda/fda-warns-cadia-and-trader-joes-organic-pineapple-recalled-due-to-possible-listeria-monocytogenes-contamination/): According to the FDA, Gresham, Oregon-based Scenic Fruit Company has voluntarily recalled its frozen organic pineapple and pineapple-containing frozen fruit blends because the Listeria monocytogenes microbe may be present in the products. - [FDA Warns – Select boxes of Deviled Crabs recalled by Santo’s Frozen Foods due to undeclared milk, sesame seeds](https://trulaw.com/fda/fda-warns-select-boxes-of-deviled-crabs-recalled-by-santos-frozen-foods-due-to-undeclared-milk-sesame-seeds/): According to the FDA, Santo's Frozen Foods, Inc. has voluntarily recalled a number of its 100-count, 36-count, and 24-count boxes of Deviled Crabs because the product may contain milk and sesame seeds, two major allergens not disclosed on packaging. - [FDA updates advisory against use of UV wands under multiple brands due to dangerous radiation levels](https://trulaw.com/fda/fda-updates-advisory-against-use-of-uv-wands-under-multiple-brands-due-to-dangerous-radiation-levels/): On June 26, 2023, the FDA alerted consumers of its expanded advisory against the use of certain brands of ultraviolet (UV) wands used for disinfection. The products under examination are believed to expose the user and any nearby person to levels of ultraviolet-C (UV-C) radiation that are considered unsafe. Even after just a few seconds of use, the products at issue may cause harm to the skin, eyes, or both. - [FDA Warns – Single lot of SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese recalled due to possible trace of Listeria monocytogenes](https://trulaw.com/fda/fda-warns-single-lot-of-sas-fromagerie-ottavi-tome-corse-sheep-milk-cheese-recalled-due-to-possible-trace-of-listeria-monocytogenes/): Brooklyn, New York-based FMA International has recalled a single lot of its SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese, which is imported from France, because of a potential Listeria monocytogenes contamination, according to the FDA. - [FDA updates recommendations regarding NuVasive Specialized Orthopedics’ Precice Devices](https://trulaw.com/fda/fda-updates-recommendations-regarding-nuvasive-specialized-orthopedics-precice-devices/): On June 28, 2023, the FDA released updated information and its own recommendations regarding the NuVasive Specialized Orthopedics' (NuVasive) Precice Intra-medullary LImb Lengthening (IMLL) system, including the Precice Short device. - [FDA Warns – Tostitos Avocado Salsa Dip recalled by Frito-Lay due to mislabeling, undeclared milk](https://trulaw.com/fda/fda-warns-tostitos-avocado-salsa-dip-recalled-by-frito-lay-due-to-mislabeling-undeclared-milk/): Frito-Lay has voluntary recalled a number of its 15 oz. jars of Tostitos Avocado Salsa Dip because the product may contain milk, an allergen not declared on the ingredient statement. - [FDA Warns – Sun Wave Brand Mini Fruit Jelly Cup (35.27oz/52.90oz) recalled due to possible choking hazard](https://trulaw.com/fda/fda-warns-sun-wave-brand-mini-fruit-jelly-cup-35-27oz-52-90oz-recalled-due-to-possible-choking-hazard/): Alhambra, California-based Richin Trading Inc. has voluntarily recalled its Sun Wave-branded Mini Fruit Jelly Cup (35.27 oz. and 52.90 oz.), in multiple flavors, because the size of the individual jelly cups presents a potential choking hazard. - [FDA Alerts – Class I recall of ARROW Endurance Extended Dwell Peripheral Catheter System due to defect](https://trulaw.com/fda/fda-alerts-class-i-recall-of-arrow-endurance-extended-dwell-peripheral-catheter-system-due-to-defect/): Teleflex and Arrow International have recalled ARROW Endurance Extended Dwell Peripheral Catheter System because the catheter was found prone to separating or leaking, according to the FDA. Due to the significant health risks ("serious injuries or death") posed by the potential issue, the recall has been labeled Class I, the most serious type. - [FDA Warns – Gelato Boy recalls Chocolate Chunk Gelato due to mislabeling, undeclared milk](https://trulaw.com/fda/fda-warns-gelato-boy-recalls-chocolate-chunk-gelato-due-to-mislabeling-undeclared-milk/): According to the FDA, Boulder, Colorado-based Gelato Boy has recalled 728 cases containing 5,824 units of its Chocolate Chunk Gelato because the product may contain milk, an allergen not declared on the packaging's ingredient statement. - [FDA UPDATE – Cricket Creek Farm’s cheese recall expanded to include lot of Berkshire Bloom cheese](https://trulaw.com/fda/fda-update-cricket-creek-farms-cheese-recall-expanded-to-include-lot-of-berkshire-bloom-cheese/): Due to inadequate pasteurization, one lot of Berkshire Bloom cheese has now been added to Cricket Creek Farm's cheese recall, which originally only included its Sophelise and Tobasi cheeses because of a possible Listeria monocytogenes contamination, according to the FDA. - [FDA Warns – Havasu Nutrition Beet Root Powder+ recalled by Supplement Manufacturing Partner, Inc. due to undeclared milk](https://trulaw.com/fda/fda-warns-havasu-nutrition-beet-root-powder-recalled-by-supplement-manufacturing-partner-inc-due-to-undeclared-milk/): According to the FDA, Supplement Manufacturing Partner, Inc. has issued an allergy alert and recalled its Havasu Nutrition Beet Root Power+ because the product has been proven to contain milk, an allergen not declared in its ingredient statement. - [FDA Alerts – Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg recalled due to mislabeling](https://trulaw.com/fda/fda-alerts-dronabinol-capsules-usp-2-5-mg-and-ziprasidone-hydrochloride-capsules-20-mg-recalled-due-to-mislabeling/): The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories, based in La Vergne, Tennessee, is voluntarily recalling a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg because of a label mix-up, according to the FDA. - [FDA Warns – 16 oz tubs of Regal Gourmet Snacks Milk Chocolate Raisins recalled due to undeclared peanuts](https://trulaw.com/fda/fda-warns-16-oz-tubs-of-regal-gourmet-snacks-milk-chocolate-raisins-recalled-due-to-undeclared-peanuts/): Chicago, Illinois-based Regal Health Food International, Inc. has recalled its 16-ounce tubs of Regal Gourmet Snacks Milk Chocolate Raisins because undeclared peanuts may be present in the product, according to the FDA. - [FDA Warns – Organic Daybreak Blend, sold in 2022, recalled by Wawona Frozen Foods due to possible trace of Hepatitis A](https://trulaw.com/fda/fda-warns-organic-daybreak-blend-sold-in-2022-recalled-by-wawona-frozen-foods-due-to-possible-trace-of-hepatitis-a/): On June 8, 2023, Wawona Frozen Foods, Inc. announced a voluntary recall of its Organic DayBreak Blend, processed and sold in 2022, because the product's Mexico-grown organic frozen strawberries may have been contaminated with Hepatitis A, according to the FDA. - [FDA Warns – Wegmans Penne Rigate Mozzarella Salad recalled by A.S.K. Foods, Inc. due to undeclared milk](https://trulaw.com/fda/fda-warns-wegmans-penne-rigate-mozzarella-salad-recalled-by-a-s-k-foods-inc-due-to-undeclared-milk/): According to the FDA, Palmyra, Pennsylvania-based A.S.K. Foods, Inc. has voluntarily recalled certain 30 oz. containers of its Wegmans Penne Rigate Mozzarella Salad because the product may contain milk, an allergen not listed in its ingredient statement. - [FDA UPDATE: Class I recall of Rechargeable Walnut Wearable Smart Thermometer by BearCare, Inc.](https://trulaw.com/fda/fda-update-class-i-recall-of-rechargeable-walnut-wearable-smart-thermometer-by-bearcare-inc/): On June 12, 2023, the FDA announced that the May 12, 2023 recall of BearCare, Inc.'s Rechargeable Walnut Wearable Smart Thermometer has been labeled Class I, due to risk of serious injuries or death. - [FDA Warns – 3 oz. packages of OnYums “Onion Flavored Rings” recalled by Rudolph Foods due to undeclared wheat](https://trulaw.com/fda/fda-warns-3-oz-packages-of-onyums-onion-flavored-rings-recalled-by-rudolph-foods-due-to-undeclared-wheat/): Rudolph Foods, of Dallas, Texas, has recalled 39 cases of its 3-ounce packages of OnYums "Onion Flavored Rings" due to the possible presence of wheat and other sensitive, undeclared ingredients, which include monosodium glutamate and the artificial colors yellow 6, yellow 6 lake, blue 2 lake, blue 1 lake, and red 40 lake. - [FDA Alerts – Getinge/Maquet recalls Quadrox Oxygenators, certain Venous Hardshell Cardiotomy Reservoirs](https://trulaw.com/fda/fda-alerts-getinge-maquet-recalls-quadrox-oxygenators-certain-venous-hardshell-cardiotomy-reservoirs/): The FDA is calling to attention an Urgent Medical Device Removal notice sent by Getinge/Maquet to healthcare providers and facilities on May 18, 2023, which warned users against using all Quadrox Oxygenators and select Getinge/Maquet Venous Hardshell Cardiotomy Reservoirs. - [FDA Warns – Texas Pete Buffalo Wing Sauce recalled by T.W. Garner Food Company due to mislabeling, undeclared soy](https://trulaw.com/fda/fda-warns-texas-pete-buffalo-wing-sauce-recalled-by-t-w-garner-food-company-due-to-mislabeling-undeclared-soy/): According to the FDA, T.W. Garner Food Company, of Winston-Salem, North Carolina, has announced a voluntary recall of 50,688 bottles of its 12 oz. Texas Pete Buffalo Wing Sauce because some of the bottles may contain soy, an allergen not declared on the product's labeling. - [FDA Alerts – Class I recall of Impella 5.5 with SmartAssist by Abiomed due to purge fluid leaks, serious health risk](https://trulaw.com/fda/fda-alerts-class-i-recall-of-impella-5-5-with-smartassist-by-abiomed-due-to-purge-fluid-leaks-serious-health-risk/): According the FDA, a recall of certain Impella 5.5 with SmartAssist sets that was initiated by Abiomed on April 17, 2023, has since been labeled Class I, the most serious type, due to a risk of major injuries or death. - [FDA Warns – Tastykake Chocolate Kandy Kakes recalled by Flower Foods due to undeclared peanuts](https://trulaw.com/fda/fda-warns-tastykake-chocolate-kandy-kakes-recalled-by-flower-foods-due-to-undeclared-peanuts/): Flower Foods, Inc., headquartered in Thomasville, Georgia, has voluntarily recalled select Tastykake Chocolate Kandy Kakes because the products may contain peanuts not disclosed on packaging, according to the FDA. - [FDA recommends conservation strategies amid shortage of non-sterile, single-use pneumatic tourniquet cuffs](https://trulaw.com/fda/fda-recommends-conservation-strategies-amid-shortage-of-non-sterile-single-use-pneumatic-tourniquet-cuffs/): On June 5, 2023, the FDA issued a letter to healthcare providers addressing the supply constraints of non-sterile, single-use pneumatic tourniquet cuffs impacting the U.S. - [FDA Warns – Sophelise, Tobasi cheeses recalled by Cricket Creek Farm, LLC due to possible trace of Listeria monocytogenes](https://trulaw.com/fda/fda-warns-sophelise-tobasi-cheeses-recalled-by-cricket-creek-farm-llc-due-to-possible-trace-of-listeria-monocytogenes/): On May 30, 2023, Williamstown, Massachusetts-based Cricket Creek Farm, LLC announced a recall of 165 units of its Sophelise cheese and 149 pounds of its Tobasi cheese because the products may be contaminated with the microbe Listeria monocytogenes, according to the FDA. - [FDA Warns – Multiple 6oz packages of Tetas Mireya popsicles recalled by DIBE LLC due to undeclared allergens](https://trulaw.com/fda/fda-warns-multiple-6oz-packages-of-tetas-mireya-popsicles-recalled-by-dibe-llc-due-to-undeclared-allergens/): Miami, Florida-based DIBE LLC has announced a recall of its 6-ounce packages of Tetas Mireya brand food popsicles in Sabor Nutella, Toddy, Ferrero, Galleta Maria, and Galleta Oreo because the products may contain a number of allergens not disclosed on packaging, reports the FDA. - [FDA requiring boxed warning updates for prescription stimulants used to treat ADHD, other conditions](https://trulaw.com/fda/fda-requiring-boxed-warning-updates-for-prescription-stimulants-used-to-treat-adhd-other-conditions/): On May 26, 2023, the FDA announced it is requiring updates to the boxed warning and other information found on the label of prescription stimulants used in the treatment of attention deficit/hyperactivity disorder (ADHD), binge-eating disorder, and narcolepsy. - [FDA Warns – Single lot of Vanilla Crunch Dark Chocolate Bar recalled by Hu Products due to undeclared tree nuts](https://trulaw.com/fda/fda-warns-single-lot-of-vanilla-crunch-dark-chocolate-bar-recalled-by-hu-products-due-to-undeclared-tree-nuts/): According to the FDA, Austin, Texas-based Hu Products has voluntarily recalled a single production lot of its Vanilla Crunch Dark Chocolate Bar (2.1 oz bar) because a number of packages may contain hazelnut, cashew, and/or almond that was not disclosed on product labeling. - [FDA Alerts – Class I recall of Seattle PAP Plus, Breathing Circuit/Anesthesia Kits by Draeger Medical due to possible defect](https://trulaw.com/fda/fda-alerts-class-i-recall-of-seattle-pap-plus-breathing-circuit-anesthesia-kits-by-draeger-medical-due-to-possible-defect/): The FDA has identified a Class I recall of the Seattle-Positive Airway Pressure (PAP) Plus system and breathing circuit and/or anesthesia kits by Draeger Medical due to a manufacturing error. - [FDA Warns – Chile Cacahuates Japones, 5oz Value Size recalled by Werner Gourmet Snacks due to undeclared peanut](https://trulaw.com/fda/fda-warns-chile-cacahuates-japones-5oz-value-size-recalled-by-werner-gourmet-snacks-due-to-undeclared-peanut/): According to the FDA, Werner Gourmet Meat Snacks has issued an allergy alert and voluntarily recalled 14,682 packages of its Chile Cacahuates Japones, 5oz Value Size, because the products may contain peanut, an allergen not disclosed on packaging. - [FDA Alerts – G-Suppress DX Pediatric Drops recalled by Novis PR LLC due to potential mislabeling](https://trulaw.com/fda/fda-alerts-g-suppress-dx-pediatric-drops-recalled-by-novis-pr-llc-due-to-potential-mislabeling/): Novis PR LLC, of San Juan, Puerto Rico, has announced a voluntarily recall of one lot (Lot D20911, expiration date 10/25) of its G-Suppress DX Pediatric Drops at the consumer level because some cartons may contain an incorrect product that is not under a Novis PR LLC brand, according to the FDA. - [FDA Warns – Meijer recalls Frederik’s Dark Chocolate Almonds, Meijer Express Go Cup Dark Chocolate due to undeclared milk](https://trulaw.com/fda/fda-warns-meijer-recalls-frederiks-dark-chocolate-almonds-meijer-express-go-cup-dark-chocolate-due-to-undeclared-milk/): According to the FDA, Grand Rapids, Michigan-based Meijer and its supplier, Lamontagne Chocolate Corp., is recalling Frederik's Dark Chocolate Almonds and Meijer Express Go Cup Dark Chocolate Almonds because the products may contain milk, which is not declared on packaging. - [FDA Alerts – Class I recall of replacement batteries for Plum 360, Plum A+, Plum A+3 Infusion Systems by ICU Medical](https://trulaw.com/fda/fda-alerts-class-i-recall-of-replacement-batteries-for-plum-360-plum-a-plum-a3-infusion-systems-by-icu-medical/): ICU Medical has recalled the replacement batteries for its Plum 360, Plum A+, and Plum A+3 Infusion Systems because of a manufacturing defect that diminishes battery life, according to the FDA. - [FDA Warns – Multiple brands of kale, spinach, collard green products recalled by Lancaster Foods due to Listeria risk](https://trulaw.com/fda/fda-warns-multiple-brands-of-kale-spinach-collard-green-products-recalled-by-lancaster-foods-due-to-listeria-risk/): On May 12, 2023, Lancaster Foods announced an update to its May 5, 2023 voluntary recall to include Lancaster Brand Spinach, listed under item #41714 and "Best If Used By" date April 29, 2023, due to a potential Listeria monocytogenes contamination. - [FDA Warns – LiDestri Food Co. Recalls Wegmans Pasta Sauce due to Undeclared Fish Allergen](https://trulaw.com/fda/fda-warns-lidestri-food-co-recalls-wegmans-pasta-sauce-due-to-undeclared-fish-allergen/): LiDestri Foods has initiated a recall of 24-ounce jars of Wegman's Italian Classics Diavolo pasta sauce due to the potential presence of undeclared fish, specifically anchovy, within the product. - [FDA Warns – Wholesale Grocers, Inc. Issues Recall of Gerber® Good Start® SootheProTM Powdered Infant Formula](https://trulaw.com/fda/fda-warns-wholesale-grocers-inc-issues-recall-of-gerber-good-start-sootheprotm-powdered-infant-formula/): According to the FDA, the Perrigo Company has taken the proactive step of issuing a voluntary recall for specific batches of Gerber® Good Start® SootheProTM Powdered Infant Formula in the United States. - [FDA alerts – Rechargeable Walnut Thermometer recalled by BearCare, Inc. due to risk of burns, other injuries](https://trulaw.com/fda/fda-alerts-rechargeable-walnut-thermometer-recalled-by-bearcare-inc-due-to-risk-of-burns-other-injuries/): According to the FDA, BearCare, Inc.'s rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) has been voluntarily recalled following user reports of injuries that include skin burns. - [FDA warns – 8.55-oz packages of Turkey and Havarti Sandwiches recalled by GHGA, LLC due to undeclared sesame](https://trulaw.com/fda/fda-warns-8-55-oz-packages-of-turkey-and-havarti-sandwiches-recalled-by-ghga-llc-due-to-undeclared-sesame/): According to the FDA, 8.55-ounce unbranded packages of turkey and havarti sandwiches were voluntarily recalled by GHGA, LLC on April 27, 2023 because the bread contains sesame that was not declared on the product label's list of allergens. - [UPDATE: FDA clears Renuvion/J-Plasma Device for select aesthetic procedures](https://trulaw.com/fda/update-fda-clears-renuvion-j-plasma-device-for-select-aesthetic-procedures/): On May 10, 2023, the FDA issued an update on approved uses of Apyx Medical's Renuvion/J-Plasma device system for select aesthetic skin procedures, including the clearance of a Renuvion/J-Plasma hand piece. - [FDA warns – Chang Farm recalls 10-lb, 12-oz bags of mung bean sprouts due to potential presence of Listeria](https://trulaw.com/fda/fda-warns-chang-farm-recalls-10-lb-12-oz-bags-of-mung-bean-sprouts-due-to-potential-presence-of-listeria/): On May 5, 2023, Chang Farm announced a voluntary recall of all 10-pound bags and 12-ounce retail bags of its Chang Farm and Nature's Wonder-branded Mung Bean Sprouts because the product may be contaminated by the bacteria Listeria monocytogenes. - [FDA warns – Consumers asked to stop use, dispose of certain Pilot COVID-19 At-Home Tests due to contamination](https://trulaw.com/fda/fda-warns-consumers-asked-to-stop-use-dispose-of-certain-pilot-covid-19-at-home-tests-due-to-contamination/): According to the FDA, Seoul, South Korea-based SD Biosensor, Inc. is requesting that U.S. consumers discontinue use and dispose of select Pilot COVID-19 At-Home Tests because one of the product's components was found to be contaminated with possibly harmful bacteria. - [FDA warns – single lot of “Spice” Packaged Salad Greens recalled by Lēf Farms due to possible E. coli contamination](https://trulaw.com/fda/fda-warns-single-lot-of-spice-packaged-salad-greens-recalled-by-lef-farms-due-to-possible-e-coli-contamination/): Loudon, New Hampshire-based Lēf Farms has announced a voluntary recall of one lot of its "Spice" Packaged Salad Greens (under "best by" date 5/5/23, lot number SP10723-1RGH1, and UPC 8 50439 00709 1) because it may contain traces of the bacteria Escherichia coli 0157:H7 (E. coli), according to the FDA. - [FDA warns – Select over-the-counter drug products recalled by Family Dollar due to improper storage](https://trulaw.com/fda/fda-warns-select-over-the-counter-drug-products-recalled-by-family-dollar-due-to-improper-storage/): On May 4, 2023, Family Dollar announced a voluntary recall of select over-the-counter drug products after officials learned the products were not stored according to their labeled temperature requirements, reports the FDA. - [FDA warns – select Culinaria Nut Mixes may contain undeclared almonds, other ingredients](https://trulaw.com/fda/fda-warns-select-culinaria-nut-mixes-may-contain-undeclared-almonds-other-ingredients/): Due to a labeling issue, St. Louis, Missouri-based Schnucks Markets, Inc., is warning consumers of possible undeclared almonds in its Culinaria Cashew & Macadamia Mix and of a possibly incorrect ingredient list printed on the label of its Cashew & Almond Mix. - [FDA warns – Copitas, ceramic cups used for drinking mezcal, recalled by Del Maguey due to potential health risk](https://trulaw.com/fda/fda-warns-copitas-ceramic-cups-used-for-drinking-mezcal-recalled-by-del-maguey-due-to-potential-health-risk/): Del Maguey Co., headquartered in New York, New York, has announced a voluntary recall of a number of its "copitas," small ceramic artisan cups designed to be used for drinking mezcal, because they may contain a level of leachable lead that exceeds FDA guidance. - [FDA warns against use of Max-Lux Safe-T-Lite UV Wand due to risks of injury](https://trulaw.com/fda/fda-warns-against-use-of-max-lux-safe-t-lite-uv-wand-due-to-risks-of-injury/): The FDA is calling to attention the risk of exposure to harmful levels of radiation during use of the Safe-T-Lite UV Wand manufactured by Max-Lux Corporation Limited. Officials say that even after a few seconds of use, the device could expose its user and/or a nearby person to high levels of ultraviolet-C (UV-C) radiation, which could injure the skin and/or eyes. - [FDA warns – General Mills recalls certain bags of Gold Medal Unbleached and Bleached All Purpose Flour due to Salmonella scare](https://trulaw.com/fda/fda-warns-general-mills-recalls-certain-bags-of-gold-medal-unbleached-and-bleached-all-purpose-flour-due-to-salmonella-scare/): According to the FDA, certain two-, five- and 10-pound bags of Gold Medal Unbleached and Bleached All Purpose Flour with "better if used by" dates of March 27, 2024, and March 28, 2024, have been voluntary recalled by General Mills due to a potential Salmonella Infantis contamination. - [FDA alerts – certain lots of Fentanyl Buccal Tablets CII recalled by Teva due to labeling issue](https://trulaw.com/fda/fda-alerts-certain-lots-of-fentanyl-buccal-tablets-cii-recalled-by-teva-due-to-labeling-issue/): Teva Pharmaceuticals USA, of Parsippany, New Jersey, has voluntarily recalled certain lots of its Fentanyl Buccal Tablets CII in various strengths because of a labeling error, according to the FDA. - [FDA warns – Vanilla Bean Yogurt 4oz cups recalled by Ellenos Real Greek LLC due to undeclared egg](https://trulaw.com/fda/fda-warns-vanilla-bean-yogurt-4oz-cups-recalled-by-ellenos-real-greek-llc-due-to-undeclared-egg/): On April 25, 2023, Ellenos Real Greek LLC announced a recall of its Vanilla Bean Greek Yogurt 4oz. cups, which are packaged in a Costco variety 12-pack (item #1340833), due to the potential presence of undeclared egg. - [FDA warns of cybersecurity vulnerability in Illumina’s Universal Copy Service Software, possible risks to patients](https://trulaw.com/fda/fda-warns-of-cybersecurity-vulnerability-in-illuminas-universal-copy-service-software-possible-risks-to-patients/): In a letter sent to healthcare providers and laboratory personnel on April 5, 2023, the FDA warned of a cybersecurity vulnerability in the Universal Copy Service (UCS) software used in several Illumina DNA-sequencing instruments, including MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000. The medical devices are used to sequence an individual's DNA to check for a number of genetic conditions during clinical diagnoses and are also specified for research use only (RUO). - [FDA Warns – Ground cumin recalled by Lipari Foods due to possible salmonella contamination](https://trulaw.com/fda/fda-warns-ground-cumin-recalled-by-lipari-foods-due-to-possible-salmonella-contamination/): Lipari Foods, headquartered in Warren, Michigan, has voluntarily recalled one lot of its Lipari Foods-branded ground cumin tubs because of a potential Salmonella contamination, according to the FDA. - [FDA Warns – Multiple human and animal drug products recalled by Akorn due to company bankruptcy](https://trulaw.com/fda/fda-warns-multiple-human-and-animal-drug-products-recalled-by-akorn-due-to-company-bankruptcy/): According to the FDA, Gurnee, Illinois-based Akorn Operating Company LLC announced a Chapter 7 bankruptcy on February 23, 2023, which led to the voluntary recall of multiple within-expiry human and animal drug products. - [FDA Warns — 5 products with Tandoori flavor recalled by Jabsons Foods PVT LTD due to undeclared milk](https://trulaw.com/fda/fda-warns-5-products-with-tandoori-flavor-recalled-by-jabsons-foods-pvt-ltd-due-to-undeclared-milk/): According to the FDA, Jabsons Foods PVT LTD has voluntarily recalled five of its products, including "Tandoori Roasted Chana (Chick Peas)", "Tandoori Roasted Peanut", "Tandoori KajuCashew Nuts", "Tandoori Peanut Spread", and "Thai Sweet Chilli Roasted Peanuts," because their packaging does not declare the presence of the milk allergen. - [FDA Alerts — Class I recall of certain BALLARD ACCESS Closed Suction Systems for Neonates, Pediatrics due to risk of serious injury or death](https://trulaw.com/fda/fda-alerts-class-i-recall-of-certain-ballard-access-closed-suction-systems-for-neonates-pediatrics-due-to-risk-of-serious-injury-or-death/): The FDA is calling to attention a Class I recall of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold/Elbow Manifold because cracked manifolds in the product may put patients at risk of inadequate ventilation and other major, possibly life-threatening injuries. - [FDA Warns — Recall of Blue Crab Dip, Cocktail Sauce, Cole Slaw, Crabcake packages by Washington Crab due to undeclared allergens](https://trulaw.com/fda/fda-warns-recall-of-blue-crab-dip-cocktail-sauce-cole-slaw-crabcake-packages-by-washington-crab-due-to-undeclared-allergens/): On April 17, 2023, Washington Crab & Seafood Company announced a recall of its Blue Crab Dip 8oz, Cocktail Sauce 8oz, Cole Slaw 8oz and 16oz, and Crabcake in 2-, 6- and 12-count packages because of undeclared milk, egg, wheat, fish, and soy allergens. - [FDA Warns — Madras Curry Powder recalled by Trong Foods International due to undeclared peanuts](https://trulaw.com/fda/fda-warns-madras-curry-powder-recalled-by-trong-foods-international-due-to-undeclared-peanuts/): On April 19, 2023, Trong Foods International issued an allergy alert and recall of certain bottles and packages of its Madras Curry Powder (Cà Ri Nị Ấn Độ "Kim Tự  Tháp") because the product may contain undisclosed peanuts. Affected products include 4-ounce bottles, 16-ounce bottles, and 4-ounce bags. - [Fresenius Kabi USA, LLC Issues Recall for Ivenix Infusion System Due to Fluid Leak That Could Cause Treatment Interruptions](https://trulaw.com/fda/fresenius-kabi-usa-llc-issues-recall-for-ivenix-infusion-system-due-to-fluid-leak-that-could-cause-treatment-interruptions/): Fresenius Kabi USA, LLC is initiating a recall of the Ivenix Infusion System due to a system leak that allows fluid to enter the Administration Set Loading Area near the Air Detector. This leak can cause damage to the electrical system, resulting in power loss and failure of the Set Identification (Set ID) sensor. - [Wismettac Asian Foods, Inc. recalls Ajhei Sanuki Udon Noodle due to undeclared fish allergen](https://trulaw.com/fda/wismettac-asian-foods-inc-recalls-ajhei-sanuki-udon-noodle-due-to-undeclared-fish-allergen/): SANTA FE SPRINGS, CA - Wismettac Asian Foods, Inc. issued a voluntary recall for 19.04 oz packages of Shirakiku brand Ajhei Sanuki Udon Noodle due to the presence of an undeclared allergen. - [Rico Perez Products, Inc. recalls ‘Dr. Rico Perez Super Kids Colostrum’ chewable tablets due to undeclared milk allergen](https://trulaw.com/fda/rico-perez-products-inc-recalls-dr-rico-perez-super-kids-colostrum-chewable-tablets-due-to-undeclared-milk-allergen/): MIAMI, FL - Rico Perez Products, Inc. has issued a voluntary recall of 60-count bottles of Dr. Rico Perez Super Kids Colostrum chewable tablets on April 13, 2023. - [FDA Warns – Recall of White Cheddar Cheese Popped Water Lily Seeds by Karma Spices and Trading Company, LLC due to undeclared milk](https://trulaw.com/fda/fda-warns-recall-of-white-cheddar-cheese-popped-water-lily-seeds-by-karma-spices-and-trading-company-llc-due-to-undeclared-milk/): Karma Spices and Trading Company, LLC has issued an allergy alert and recall of its White Cheddar Cheese Popped Water Lily Seeds because undeclared milk may be present in the product, according to the FDA.  - [FDA Warns – Multiple packages containing lettuce recalled by Revolution Farms due to risk of Listeria contamination ](https://trulaw.com/fda/fda-warns-multiple-packages-containing-lettuce-recalled-by-revolution-farms-due-to-risk-of-listeria-contamination/): According to the FDA, Caledonia, Michigan-based Revolution Farms has voluntarily recalled as many as 15 products containing lettuce because they may be contaminated by Listeria monocytogenes.  - [FDA warns against use of certain O&M Halyard Surgical N95 Respirators, Surgical Masks, Pediatric Face Masks due to possible protection failure](https://trulaw.com/fda/fda-warns-against-use-of-certain-om-halyard-surgical-n95-respirators-surgical-masks-pediatric-face-masks-due-to-possible-protection-failure/): On April 12, 2023, the FDA released a safety communication alerting consumers, healthcare providers, and facilities of a risk of protection failure in certain surgical N95 respirators, surgical masks, and pediatric masks manufactured by O&M Halyard. Though select surgical masks and pediatric face masks by the company may still be effectively used with caution and in lower-risk situations, use of the brand’s surgical N95 respirators is not advised.  - [FDA Warns – Single lot of SimplyProtein Peanut Butter Chocolate Crispy Bar recalled by Wellness Natural USA Inc. due to undeclared cashews](https://trulaw.com/fda/fda-warns-single-lot-of-simplyprotein-peanut-butter-chocolate-crispy-bar-recalled-by-wellness-natural-usa-inc-due-to-undeclared-cashews/): Wilmington, Delaware-based Wellness Natural USA Inc. has issued a voluntary nationwide recall of one lot of its SimplyProtein Peanut Butter Chocolate Crispy Bar because the product may contain undeclared cashews, according to the FDA.  - [FDA Alerts – Class I recall of certain reworked Philips Respironics DreamStation CPAP, BiPAP machines due to risk of inaccurate or under-delivered therapy](https://trulaw.com/fda/fda-alerts-class-i-recall-of-certain-reworked-philips-respironics-dreamstation-cpap-bipap-machines-due-to-risk-of-inaccurate-or-under-delivered-therapy/): The FDA is calling to attention a Class I recall of certain reworked DreamStation CPAP and BiPAP machines because a number of the devices were assigned incorrect or duplicate serial numbers when they were first programmed, which could potentially result in inaccurate or insufficient therapy.  - [FDA Warns – Hundreds of cases of Biltmore Smoked Sockeye Salmon recalled by Seven Seas International USA, LLC due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-hundreds-of-cases-of-biltmore-smoked-sockeye-salmon-recalled-by-seven-seas-international-usa-llc-due-to-potential-listeria-contamination/): St. Petersburg, Florida-based Seven Seas International USA, LLC has voluntarily recalled 295 cases of its Biltmore Smoked Sockeye Salmon because some of the product may contain the microbe Listeria monocytogenes.  - [FDA Warns – Potential battery swelling and overheating in FreeStyle Libre family of Readers by Abbott](https://trulaw.com/fda/fda-warns-potential-battery-swelling-and-overheating-in-freestyle-libre-family-of-readers-by-abbott/): On April 3, 2023, the FDA issued a safety communication reminding consumers of potential battery swelling and overheating in the Reader component of Abbott’s FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. Abbott maintains that the issue does not impact any of its FreeStyle Libre family of sensors.  - [FDA Alerts – Voluntary recall of Atovaquone Oral Suspension, USP 750 mg/5mL by Camber Pharmaceuticals, Inc. due to possible Bacillus cereus contamination](https://trulaw.com/fda/fda-alerts-voluntary-recall-of-atovaquone-oral-suspension-usp-750-mg-5ml-by-camber-pharmaceuticals-inc-due-to-possible-bacillus-cereus-contamination/): According to the FDA, one lot of Atovaquone Oral Suspension, USP 750 mg/5mL has been voluntarily recalled by Camber Pharmaceuticals, Inc. at the consumer level because the product may be contaminated by Bacillus cereus.  - [FDA Warns – Single-lot recall of HyVee Hamburger Chili Macaroni Skillet Meal by Gilster-Mary Lee Corp. due to undeclared milk](https://trulaw.com/fda/fda-warns-single-lot-recall-of-hyvee-hamburger-chili-macaroni-skillet-meal-by-gilster-mary-lee-corp-due-to-undeclared-milk/): Gilster-Mary Lee Corp., of Steelville, Illinois, has recalled one lot of its HyVee Hamburger Chili Macaroni Skillet Meal to the consumer level because of undisclosed milk in the product, according to the FDA.  - [FDA issues safety alert regarding unapproved uses of dental devices, including fixed palatal expanders](https://trulaw.com/fda/fda-issues-safety-alert-regarding-unapproved-uses-of-dental-devices-including-fixed-palatal-expanders/): On March 30, 2023, the FDA issued a safety communication regarding the unapproved uses of several dental devices, like fixed (non-removable) palatal expanders, in the remodeling of jaws or treatment of conditions in adults.  - [FDA Warns – 16.9 fl oz Kagome Worcester Sauce, 16.9 fl oz Kagome Chuno Sauce recalled by North American Food Distributing Company, Inc. due to undeclared soy](https://trulaw.com/fda/fda-warns-16-9-fl-oz-kagome-worcester-sauce-16-9-fl-oz-kagome-chuno-sauce-recalled-by-north-american-food-distributing-company-inc-due-to-undeclared-soy/): According to the FDA, North American Food Distributing Company, Inc. has issued an allergy alert along with a recall of its 16.9 fluid-ounce Kagome Worcester Sauce and 16.9 fluid-ounce Kagome Chuno Sauce because of undeclared soy. - [FDA Alerts – Voluntary recall of Alcohol Antiseptic 80%, Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solutions by Jarman’s Midwest Cleaning Systems, Inc.](https://trulaw.com/fda/fda-alerts-voluntary-recall-of-alcohol-antiseptic-80-isopropyl-alcohol-antiseptic-75-topical-solution-hand-sanitizer-non-sterile-solutions-by-jarmans-midwest-cleaning-systems-inc/): Jansen’s Midwest Cleaning Systems, Inc. has announced a voluntary recall of all lots of its Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Hand Sanitizer Non-sterile Solution, according to the FDA. - [FDA reminds users of risks, recall of Exactech Joint Replacement Devices due to defective packaging](https://trulaw.com/fda/fda-reminds-users-of-risks-recall-of-exactech-joint-replacement-devices-due-to-defective-packaging/): On March 23, 2023, the FDA issued a safety communication reminding patients and healthcare providers of Exactech joint replacement devices that were recalled in 2021 and 2022.  - [FDA Warns – Second Nature Brands recalls 4-oz packages of Gluten Free Reese’s Pieces Brownie Brittle due to undeclared wheat](https://trulaw.com/fda/fda-warns-second-nature-brands-recalls-4-oz-packages-of-gluten-free-reeses-pieces-brownie-brittle-due-to-undeclared-wheat/): On March 23, 2023, Second Natures Brands announced a nationwide recall of its 4-ounce packages of Gluten Free Reese’s Pieces Brownie Brittle due to undeclared wheat, according to the FDA. - [FDA Warns – 8-count packages of “Our Family White Hot Dog Buns” recalled by Perfection Bakeries D/B/A Aunt Millie’s due to undeclared sesame](https://trulaw.com/fda/fda-warns-8-count-packages-of-our-family-white-hot-dog-buns-recalled-by-perfection-bakeries-d-b-a-aunt-millies-due-to-undeclared-sesame/): On March 22, 2023, Perfection Bakeries D/B/A Aunt Millie’s announced a recall of its 8-count packages of “Our Family White Hot Dog Buns” because they may contain sesame, which is not an allergen declared on the product labeling. - [FDA Alerts – Voluntary recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg by Ascend Laboratories LLC due to impurity](https://trulaw.com/fda/fda-alerts-voluntary-recall-of-dabigatran-etexilate-capsules-usp-75-mg-and-150-mg-by-ascend-laboratories-llc-due-to-impurity/): According to the FDA, Ascend Laboratories LLC, headquartered in Parsippany, New Jersey, has voluntarily recalled its Dabigatran Etexilate Capsules, USP, 75 mg and 150 mg, to the consumer level. - [FDA Alerts – Scenic Fruit Company recalls Frozen Organic Strawberries and fruit blend under multiple brands due to Hepatitis A scare](https://trulaw.com/fda/fda-alerts-scenic-fruit-company-recalls-frozen-organic-strawberries-and-fruit-blend-under-multiple-brands-due-to-hepatitis-a-scare/): Gresham, Oregon-based Scenic Fruit Company has recalled its frozen organic strawberries and frozen organic tropical blend from the shelves of its retail partners in response to a recent outbreak of Hepatitis A illnesses. - [FDA Warns – Voluntary recall of 13 lots of Gerber Good Start SootheProTM Powdered Infant Formula due to potential Cronobacter sakazakii contamination](https://trulaw.com/fda/fda-warns-voluntary-recall-of-13-lots-of-gerber-good-start-sootheprotm-powdered-infant-formula-due-to-potential-cronobacter-sakazakii-contamination/): According to the FDA, on March 17, 2023, a limited quantity of Gerber Good Start SootheProTM Powdered Infant Formula was recalled by Perrigo Company plc as a precautionary measure against a possible Cronobacter sakazakii contamination. - [FDA Alerts – Class I recall of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to risk of unexpected shutdown](https://trulaw.com/fda/fda-alerts-class-i-recall-of-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-due-to-risk-of-unexpected-shutdown/): The FDA is calling to attention an ongoing Class I recall of certain Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pumps by Datascope/Getinge. - [FDA Warns – California Splendor, Inc. recalls select lots of Kirkland Signature Frozen Organic Strawberries sold in Los Angeles, San Diego, Hawaii Costco stores](https://trulaw.com/fda/fda-warns-california-splendor-inc-recalls-select-lots-of-kirkland-signature-frozen-organic-strawberries-sold-in-los-angeles-san-diego-hawaii-costco-stores/): On March 16, select lots of Kirkland Signature Frozen Strawberries 4-pound bags were recalled by California Splendor, Inc. as a precautionary measure after an outbreak of Hepatitis A illnesses. According to the FDA, the affected products were distributed at Costco locations in Hawaii, Los Angeles, and two business centers in San Diego. - [FDA Warns – Regional recall of Strawberry Granola & Greek Yogurt Parfait Bar by NJ-based Clio Snacks due to potential Listeria contamination](https://trulaw.com/fda/fda-warns-regional-recall-of-strawberry-granola-greek-yogurt-parfait-bar-by-nj-based-clio-snacks-due-to-potential-listeria-contamination/): According to the FDA, 581 cases of Strawberry Granola & Greek Yogurt Parfait Bars by Clio Snacks have been voluntarily recalled after a risk of contamination with the organism Listeria monocytogenes was identified. - [FDA Alerts – 2 more lots included in recall of Purina Pro Plan Veterinary Diets EL Elemental Dry Dog Food by Nestlé Purina Petcare Company](https://trulaw.com/fda/fda-alerts-2-more-lots-included-in-recall-of-purina-pro-plan-veterinary-diets-el-elemental-dry-dog-food-by-nestle-purina-petcare-company/): On March 10, 2023, Nestlé Purina PetCare Company announced that two additional lots are now included in a voluntary recall of its Purina Pro Plan Veterinary Diets EL (PPVD EL) prescription dry dog food. The company’s original recall announcement was issued on February 8, 2023, after a supplier error led to potentially elevated vitamin D levels in the product due. - [FDA Alerts – Risk of cancers like Squamous Cell Carcinoma (SCC), lymphomas in scar tissue around breast implants](https://trulaw.com/fda/fda-alerts-risk-of-cancers-like-squamous-cell-carcinoma-scc-lymphomas-in-scar-tissue-around-breast-implants/): In a September 8, 2022 communication, the FDA announced it had been made aware of reports of cancers, including squamous cell carcinoma (SCC) and a number of lymphomas, in the scar tissue (capsule) of patients who had gotten breast implants. As a clarification, officials noted these particular lymphomas are not to be confused with the lymphomas noted in a prior FDA letter on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). - [FDA Warns – possible patient desaturation in Life2000 Ventilation System by Baxter International Inc. when used with oxygen concentrator](https://trulaw.com/fda/fda-warns-possible-patient-desaturation-in-life2000-ventilation-system-by-baxter-international-inc-when-used-with-oxygen-concentrator/): The FDA is calling to attention an Urgent Medical Device Correction issued by Baxter International Inc. on March 10, 2023, regarding its Life2000 Ventilation System when the product is connected to a third-party oxygen concentrator. - [FDA Alerts – “Dr. Rima Recommends Nano Silver 10ppm” dietary supplement recalled due to unsubstantiated claims](https://trulaw.com/fda/fda-alerts-dr-rima-recommends-nano-silver-10ppm-dietary-supplement-recalled-due-to-unsubstantiated-claims/): On March 7, 2023, Natural Solutions Foundation announced a recall of its “Dr. Rima Recommends Nano Silver 10ppm” dietary supplement after the FDA determined that the product labeling makes unsupported health claims about its prevention, treatment, cure of COVID-19. - [FDA to healthcare providers: be alert to possible risk of toxic compound exposure in hemodialysis and peritoneal dialysis systems](https://trulaw.com/fda/fda-to-healthcare-providers-be-alert-to-possible-risk-of-toxic-compound-exposure-in-hemodialysis-and-peritoneal-dialysis-systems/): In a communication posted on March 7, 2023, the FDA is urging healthcare professionals to be aware of potential patient exposure to toxic compounds in hemodialysis and peritoneal dialysis systems during an ongoing investigation into the issue. - [FDA Warns – Various Daiso snack items pulled from shelves due to undeclared allergens](https://trulaw.com/fda/fda-warns-various-daiso-snack-items-pulled-from-shelves-due-to-undeclared-allergens/): According to the FDA, Daiso California LLC has recalled as many as 10 pre-packaged snack products from its stores across six states due to undisclosed allergens. - [FDA Warns – Apotex Corp. voluntarily recalls 6 lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%](https://trulaw.com/fda/fda-warns-apotex-corp-voluntarily-recalls-6-lots-of-brimonidine-tartrate-ophthalmic-solution-0-15/): Six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% by Apotex Corp. have been voluntarily recalled at the consumer level, according to an FDA announcement published March 2, 2023. - [FDA Alerts – Pharmedica USA LLC recalls 2 lots of Purely Soothing 15% MSM Drops](https://trulaw.com/fda/fda-alerts-pharmedica-usa-llc-recalls-2-lots-of-purely-soothing-15-msm-drops/): On March 3, 2023, Phoenix, Arizona-based Pharmedica USA LLC announced a voluntary recall of two lots of Purely Soothing, 15% MSM Drops due to non-sterility. - [FDA Warns – Russell Stover Chocolates recalls certain Sugar Free Peanut Butter Cups due to undeclared pecan](https://trulaw.com/fda/fda-warns-russell-stover-chocolates-recalls-certain-sugar-free-peanut-butter-cups-due-to-undeclared-pecan/): Kansas City, Missouri-based Russell Stover Chocolates has issued an allergy alert and a voluntary recall of its Sugar Free Peanut Butter Cups under two Best-Before dates due to possible undeclared pecans, reports the FDA. - [TruLaw Alerts – Getinge/Maquet recalls HLS Set Advanced of Cardiohelp System due to possible insufficient packaging sterility](https://trulaw.com/fda/trulaw-alerts-getinge-maquet-recalls-hls-set-advanced-of-cardiohelp-system-due-to-possible-insufficient-packaging-sterility/): The FDA is informing healthcare providers of an issue regarding potential insufficient packaging sterility in the HLS Set Advanced part of the Getinge/Maquet Cardiohelp system.  - [FDA warns of possible early structural valve deterioration in Abbott Trifecta Valves](https://trulaw.com/fda/fda-warns-of-possible-early-structural-valve-deterioration-in-abbott-trifecta-valves/): On February 27, 2023, the FDA alerted healthcare providers that it has reason to believe Abbott Trifecta valves may be subject to early structural valve deterioration (SVD). The referenced devices include both the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which come with leaflets affixed to the exterior of the valve frame. - [FDA Warns – Renuvion/J-Plasma Device by Apyx Medical cleared for only limited types of aesthetic procedures](https://trulaw.com/fda/fda-warns-renuvion-j-plasma-device-by-apyx-medical-cleared-for-only-limited-types-of-aesthetic-procedures/): On February 27, 2023, the FDA released an update to a safety communication regarding the use of Apyx Medical’s Renuvion/J-Plasma Device system in certain aesthetic skin procedures. - [FDA Alerts – 1 batch of Delsam Pharma Artificial Eye Ointment voluntarily recalled due to risk of infection, blindness](https://trulaw.com/fda/fda-alerts-1-batch-of-delsam-pharma-artificial-eye-ointment-voluntarily-recalled-due-to-risk-of-infection-blindness/): The FDA is calling to attention a voluntary recall of one batch of Delsam Pharma Artificial Eye Ointment by Global Pharma Healthcare because of potential microbial contamination. - [FDA Alerts – Bindle Bottles voluntarily recalled due to possible lead adulteration](https://trulaw.com/fda/fda-alerts-bindle-bottles-voluntarily-recalled-due-to-possible-lead-adulteration/): On February 22, 2023, Bindle Bottle LLC announced a voluntary recall of its 32-ounce, 24-ounce, 20-ounce, and 13-ounce insulated food and drink bottles after it was discovered that the product’s bottom storage compartment may contain a 0.4-inch diameter of exposed lead. - [FDA Warns – Sunny Dell Foods, LLC recalls 1 lot of Rao’s Homemade Roasted Red Peppers with Portobello Mushroom due to undeclared tree nuts](https://trulaw.com/fda/fda-warns-sunny-dell-foods-llc-recalls-1-lot-of-raos-homemade-roasted-red-peppers-with-portobello-mushroom-due-to-undeclared-tree-nuts/): Oxford, Pennsylvania-based Sunny Dell Foods, LLC has recalled one lot of its “Rao’s Homemade Brand Roasted Red Peppers with Portobello Mushrooms” because the product may have traces of pine nuts that are not disclosed in product labeling, according to the FDA. - [FDA Warns – Voluntary recall of all batches of Alcohol Antiseptic 80% Alcohol Solution by nanoMaterials Discovery Corporation](https://trulaw.com/fda/fda-warns-voluntary-recall-of-all-batches-of-alcohol-antiseptic-80-alcohol-solution-by-nanomaterials-discovery-corporation/): According to the FDA, nanoMaterials Discovery Corporation has issued a nationwide, consumer-level voluntary recall of all batches of its “Snowy Range Blue”-branded Alcohol Antiseptic 80% Alcohol Solution. - [FDA Alerts – 2 batches of Prosobee 12.9 oz Simply Plant-Based Infant Formula recalled by Reckitt](https://trulaw.com/fda/fda-alerts-2-batches-of-prosobee-12-9-oz-simply-plant-based-infant-formula-recalled-by-reckitt/): As a precautionary measure, Reckitt recalled two select batches of its ProSobee 12.9 oz. Simply Plant-Based Infant Formula on February 20, 2023, after learning of potential cross-contamination with the microbe Cronobacter sakazakii. - [FDA Alerts – Class I recall of LeadCare II, LeadCare Plus, LeadCare Ultra Blood Lead Tests by Magellan Diagnostics](https://trulaw.com/fda/fda-alerts-class-i-recall-of-leadcare-ii-leadcare-plus-leadcare-ultra-blood-lead-tests-by-magellan-diagnostics/): The FDA is alerting consumers to a number of updates regarding a Class I recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests by Magellan Diagnostics. - [FDA Warns – Silvestri Sweets recalls Favorite Day Valentine’s Milk Chocolate Covered Caramels with Nonpareils due to undeclared pecan](https://trulaw.com/fda/fda-warns-silvestri-sweets-recalls-favorite-day-valentines-milk-chocolate-covered-caramels-with-nonpareils-due-to-undeclared-pecan/): Silvestri Sweets Inc. has issued a voluntary allergy alert and recall of its Favorite Day-branded Valentine’s Milk Chocolate Covered Caramels with Nonpareils due to possible traces of undisclosed tree nuts, according to the FDA. - [FDA Alerts – Class I recall of Nuclear Medicine 600/800 Series systems by GE HealthCare due to missing parts](https://trulaw.com/fda/fda-alerts-class-i-recall-of-nuclear-medicine-600-800-series-systems-by-ge-healthcare-due-to-missing-parts/): According to the FDA, a recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems has been identified as Class I due to a potential product defect and missing part that could result in serious injury or death. - [FDA Alerts – PrimeZen Black 6000 capsules by Volt Candy recalled due to undeclared sildenafil, tadalafil](https://trulaw.com/fda/fda-alerts-primezen-black-6000-capsules-by-volt-candy-recalled-due-to-undeclared-sildenafil-tadalafil/): Volt Candy, of Pomona, California, has voluntarily recalled one lot of its PrimeZen Black 6000 capsules at the consumer level after an FDA analysis yielded traces of undeclared sildenafil and tadalafil in the product. - [FDA Alerts – Advanced Women Imaging, operators lose Mammography Quality Standards Act (MQSA) accreditation until Jan. 2025](https://trulaw.com/fda/fda-alerts-advanced-women-imaging-operators-lose-mammography-quality-standards-act-mqsa-accreditation-until-jan-2025/): In an updated communication posted on February 7, 2023, the FDA is alerting patients that Guttenberg, New Jersey-based Advanced Women Imaging has had its Mammography Quality Standards Act (MQSA) certificate revoked until January 4, 2025. - [FDA Warns – “JSJ Chocolate Cake,” “JSJ ZSR Cake,” and “JSJ DMC Leaf Cake” recalled by Titans Global Inc due to undeclared egg](https://trulaw.com/fda/fda-warns-jsj-chocolate-cake-jsj-zsr-cake-and-jsj-dmc-leaf-cake-recalled-by-titans-global-inc-due-to-undeclared-egg/): In an allergy alert issued on February 4, 2023, Titans Global Inc indicated it was recalling its “JSJ Chocolate Cake,” “JSJ ZSR Cake,” and “JSJ DMC Leaf Cake” because the ingredient list printed on all product labeling does not declare egg as a possible allergen. - [FDA Alerts – Class I recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test updated to include additional distributor](https://trulaw.com/fda/fda-alerts-class-i-recall-of-skippack-medical-lab-sars-cov-2-antigen-rapid-test-updated-to-include-additional-distributor/): In a February 8, 2023 update to a safety communication regarding a Class I recall of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test, the FDA has named Universal Meditech Inc. as another distributor of the unapproved product. - [FDA Warns – Class I recall of CADD Infusion System Administration Sets and Cassette Reservoirs by Smiths Medical due to product defects](https://trulaw.com/fda/fda-warns-class-i-recall-of-cadd-infusion-system-administration-sets-and-cassette-reservoirs-by-smiths-medical-due-to-product-defects/): According to the FDA, a recall of CADD System Administration Sets and Cassette Reservoirs by Smiths Medical has been identified as Class I due to issues that may cause major injuries or death. - [FDA Alerts – Hundreds of ready-to-eat sandwiches, other products recalled by Fresh Ideation Food Group LLC due to potential Listeria contamination](https://trulaw.com/fda/fda-alerts-hundreds-of-ready-to-eat-sandwiches-other-products-recalled-by-fresh-ideation-food-group-llc-due-to-potential-listeria-contamination/): According to the FDA, Baltimore, Maryland-based Fresh Ideation Food Group LLC has initiated a recall of hundreds of ready-to-eat sandwiches and other food products under multiple brands. - [FDA Warns – Global Health Pharma Healthcare recalls Artificial Tears Lubricant Eye Drops distributed by EzriCare & Delsam Pharma](https://trulaw.com/fda/fda-warns-global-health-pharma-healthcare-recalls-artificial-tears-lubricant-eye-drops-distributed-by-ezricare-delsam-pharma/): The FDA is calling to attention a voluntary recall to the consumer level of Artificial Tears Lubricant Eye Drops by Global Health Pharma Healthcare due to potential contamination. - [FDA Alerts – “Diep Bao Cream” by Shop Me Ca recalled due to potential lead contamination](https://trulaw.com/fda/fda-alerts-diep-bao-cream-by-shop-me-ca-recalled-due-to-potential-lead-contamination/): Herndon, Virginia-based Shop Me Ca has voluntarily recalled its “Diep Bao Cream,” a baby skin cream, after testing by Oregon Health Authority (OHA) detected high lead levels in two samples, according to the FDA. - [FDA Alerts – Philips Respironics issues Class I recall of multiple masks for BiPAP, CPAP machines due to danger posed by magnetic clips](https://trulaw.com/fda/fda-alerts-philips-respironics-issues-class-i-recall-of-multiple-masks-for-bipap-cpap-machines-due-to-danger-posed-by-magnetic-clips/): According to the FDA, Philips Respironics has recalled several masks for BiPAP and CPAP machines after officials learned the magnetic clips used to hold them in place could cause potential injury or death. - [FDA Warns – Joy Joy’s Bakery recalls Ube Spanish Bread, Ube Ensaymada, and Ube Roll due to undeclared wheat](https://trulaw.com/fda/fda-warns-joy-joys-bakery-recalls-ube-spanish-bread-ube-ensaymada-and-ube-roll-due-to-undeclared-wheat/): Lakewood, Washington-based Joy Joy’s Bakery has recalled its Ube Spanish Bread, Ube Ensaymada, and Ube Roll due to inadequate disclosure of wheat allergen on product labels, according to the FDA. - [FDA Alert – Expanded recall of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 by Edgewell Personal Care](https://trulaw.com/fda/fda-alert-expanded-recall-of-banana-boat-hair-scalp-sunscreen-spray-spf-30-by-edgewell-personal-care/): The FDA is alerting consumers to an important update of a July 29, 2022 recall of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 by Edgewell Personal Care due to trace levels of benzene. - [FDA Alerts – Emergent recalls batch of RSDL (Reactive Skin Decontamination Lotion) kits under Class I after reported leaks](https://trulaw.com/fda/fda-alerts-emergent-recalls-batch-of-rsdl-reactive-skin-decontamination-lotion-kits-under-class-i-after-reported-leaks/): A November 24, 2022 recall of RSDL (Reactive Skin Decontamination Lotion) kits by Emergent has been labeled Class I due to product leak potential that may result in major injuries or death, according to the FDA. - [FDA Warns – Almondy recalls batch of Almondy Chocolate Cake with Daim 14.1oz](https://trulaw.com/fda/fda-warns-almondy-recalls-batch-of-almondy-chocolate-cake-with-daim-14-1oz/): According to the FDA, Almondy announced a recall of a select number of its Almondy Chocolate Cake with Daim 14.1oz on January 25, 2023, after a foreign metal object was discovered in the cake. As a precautionary measure, the company decided to recall an entire batch of the product. - [FDA Warning – Class I recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps by Datascope/Getinge](https://trulaw.com/fda/fda-warning-class-i-recall-of-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-by-datascope-getinge/): The FDA is calling to attention a Class I recall of Datascope’s Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to potential patient harm. - [FDA Alerts – Corim Industries updates press release regarding recall of peanut butter hot chocolate products](https://trulaw.com/fda/fda-alerts-corim-industries-updates-press-release-regarding-recall-of-peanut-butter-hot-chocolate-products/): On January 23, 2023, Corim Industries amended language in its announcement regarding the voluntary recall of several peanut butter hot chocolate products due to undeclared peanut allergen. - [FDA alerts to recall of select Dark Chocolate Cocoa Almond & Dark Chocolate Salted Caramel Cashew by SkinnyDipped](https://trulaw.com/fda/fda-alerts-to-recall-of-select-dark-chocolate-cocoa-almond-dark-chocolate-salted-caramel-cashew-by-skinnydipped/): Due to an undeclared peanut allergen, Seattle-based SkinnyDipped has voluntarily recalled a limited number of its SkinnyDipped Dark Chocolate Cocoa Almond 3.5oz and SkinnyDipped Dark Chocolate Salted Caramel Cashew 3.5oz. - [FDA Warns – Garden of Light (dba Bakery on Main) recalls one lot of Oat & Honey Organic Granola due to undeclared almond](https://trulaw.com/fda/fda-warns-garden-of-light-dba-bakery-on-main-recalls-one-lot-of-oat-honey-organic-granola-due-to-undeclared-almond/): On December 30th, 2022, Garden of Light (dba Bakery on Main) initiated a voluntary recall of one lot of its Organic Oat and Honey Granola after learning the product may be contaminated with almond. - [FDA alerts to recall of peanut butter hot chocolate products by Corim Industries due to undeclared peanuts](https://trulaw.com/fda/fda-alerts-to-recall-of-peanut-butter-hot-chocolate-products-by-corim-industries-due-to-undeclared-peanuts/): On January 18, 2023, Corim Industries announced a voluntary recall of four peanut butter hot chocolate products because they may contain peanuts not declared on the labeling, according to the FDA. - [FDA alerts to recall of alfalfa sprouts by Fullei Fresh due to contamination with Shiga toxin-producing E. Coli](https://trulaw.com/fda/fda-alerts-to-recall-of-alfalfa-sprouts-by-fullei-fresh-due-to-contamination-with-shiga-toxin-producing-e-coli/): The FDA is calling to attention a voluntary recall of Fullei Fresh’s alfalfa sprouts after Shiga toxin-producing E. coli (STEC) was detected in the finished product. - [FDA Warns – Daiso California, LLC recalls multiple Tohato and Kashiwado products due to undeclared allergens](https://trulaw.com/fda/fda-warns-daiso-california-llc-recalls-multiple-tohato-and-kashiwado-products-due-to-undeclared-allergens/): On January 10, 2023, Daiso California, LLC recalled a dozen products under the brand names Tohato and Kashiwado after it was found that their packaging does not declare all allergen ingredients. - [FDA alerts to expanded recall of Enoki Mushrooms by Utopia Foods Inc. due to potential contamination](https://trulaw.com/fda/fda-alerts-to-expanded-recall-of-enoki-mushrooms-by-utopia-foods-inc-due-to-potential-contamination/): On January 13, 2023, Glendale, New York-based Utopia Foods Inc. announced an expanded recall of its Enoki Mushrooms after the product was determined to be potentially contaminated by the organism Listeria monocytogenes. - [FDA Warns – Class I recall of Intera 3000 Hepatic Artery Infusion Pump by Intera Oncology](https://trulaw.com/fda/fda-warns-class-i-recall-of-intera-3000-hepatic-artery-infusion-pump-by-intera-oncology/): On January 13, 2023, the FDA updated a July 10, 2022 Class I recall of Intera Oncology’s Intera 3000 Hepatic Artery Infusion Pump to clarify that a failure to recognize and adjust the product’s faster-than-normal flow rates may result in major adverse health outcomes. - [FDA alerts to undeclared allergens in H-E-B Meal Simple Chocolate Chunk Brownie 13oz by Ameripack Foods, LLC](https://trulaw.com/fda/fda-alerts-to-undeclared-allergens-in-h-e-b-meal-simple-chocolate-chunk-brownie-13oz-by-ameripack-foods-llc/): The FDA is calling to attention a Texas-wide recall of 976 pounds of brownies packaged under the product H-E-B Meal Simple Chocolate Chunk Brownie 13oz by Ameripack Foods, LLC. - [FDA alerts to undeclared allergens in Gourmet Popcorn by Avery’s Savory Popcorn LLC](https://trulaw.com/fda/fda-alerts-to-undeclared-allergens-in-gourmet-popcorn-by-averys-savory-popcorn-llc/): On December 30, 2022, Avery’s Savory Popcorn LLC recalled its Gourmet Popcorn, All Flavors, due to the possibility of the product containing a number of undeclared allergens, reports the FDA. - [FDA alerts to worldwide recall of Epinephrine (L-Adrenaline) USP bulk API by Spectrum Laboratory Products, Inc.](https://trulaw.com/fda/fda-alerts-to-worldwide-recall-of-epinephrine-l-adrenaline-usp-bulk-api-by-spectrum-laboratory-products-inc/): Three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used in the manufacture of prescription products, are being voluntarily recalled to the user level by Spectrum Laboratory Products, Inc., according to the FDA. The company announced the move on January 9, 2023, after a number of customers discovered a discoloration in the product. - [FDA Warns – Lupin Pharmaceuticals Inc. recalls multiple lots of Quinapril tablets due to potential nitrosamine impurity](https://trulaw.com/fda/fda-warns-lupin-pharmaceuticals-inc-recalls-multiple-lots-of-quinapril-tablets-due-to-potential-nitrosamine-impurity/): According to the FDA, four lots of Quinapril Tablets by Lupin Pharmaceuticals Inc. were voluntarily recalled to the consumer level on December 21, 2022. The action was made after recent testing found a nitrosamine impurity, N-Nitroso-Quinapril, which registered in excess of the Acceptable Daily Intake (ADI) level. - [FDA Warns – Frozen manicotti by Caesar’s Pasta, LLC recalled due to potential contamination](https://trulaw.com/fda/fda-warns-frozen-manicotti-by-caesars-pasta-llc-recalled-due-to-potential-contamination/): On December 29, 2022, Caesar’s Pasta, LLC recalled 5,610 pounds of its frozen manicotti after a routine sampling program revealed the finished product might contain the bacteria Listeria monocytogenes, according to the FDA.  - [FDA alerts to potential issues with CADD Infusion System Infusion Sets by Smith’s Medical](https://trulaw.com/fda/fda-alerts-to-potential-issues-with-cadd-infusion-system-infusion-sets-by-smiths-medical/): On December 12, 2022, Smith’s Medical sent out an Urgent Medical Device Correction Letter to customers after identifying two potential problems with its CADD Infusion System Infusion Sets, according to the FDA. - [FDA Warns – Several lots of alfalfa sprouts from SunSprout Enterprises recalled due to salmonella scare](https://trulaw.com/fda/fda-warns-several-lots-of-alfalfa-sprouts-from-sunsprout-enterprises-recalled-due-to-salmonella-scare/): On December 29, 2022, Sunsprout Enterprises voluntarily recalled four lots of raw alfalfa sprouts due to potential salmonella contamination. - [FDA Warns – Class I recall of Hamilton-C6 Intensive Care Ventilator by Hamilton Medical AG](https://trulaw.com/fda/fda-warns-class-i-recall-of-hamilton-c6-intensive-care-ventilator-by-hamilton-medical-ag/): A June 27, 2022, recall of Hamilton Medical AG’s Hamilton-C6 Intensive Care Ventilator has since been labeled Class I by the FDA due to risks of major injuries or death. - [FDA advises discussion of alternatives for MRI-guided biopsy procedures during supply shortage](https://trulaw.com/fda/fda-advises-discussion-of-alternatives-for-mri-guided-biopsy-procedures-during-supply-shortage/): Due to an ongoing shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables, the FDA recommends that healthcare providers talk to patients about other options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures. - [FDA warns – Accord Healthcare Inc. recalls 1 lot of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial](https://trulaw.com/fda/fda-warns-accord-healthcare-inc-recalls-1-lot-of-daptomycin-for-injection-500-mg-vial-and-daptomycin-for-injection-350-mg-vial/): After receiving a report of a product mix-up, Accord Healthcare Inc. has voluntarily recalled a single lot of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial to the consumer level. - [FDA Warns – Hospira, Inc. recalls 1 lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial](https://trulaw.com/fda/fda-warns-hospira-inc-recalls-1-lot-of-vancomycin-hydrochloride-injection-usp-1-5g-vial/): The FDA is calling to attention a voluntary recall of one lot of Hospira, Inc.’s Vancomycin Hydrochloride Injection, USP 1.5g/vial Single Dose Fliptop Vial. On December 22, 2022, the company initiated the action on lot 33045BA to the user level after two glass particulates were visibly observed in one vial. - [FDA Warns – Voluntary recall of Easy Care First Aid Burn Cream and First Aid Kits by GFA Production (Xiamen) Co., Ltd.](https://trulaw.com/fda/fda-warns-voluntary-recall-of-easy-care-first-aid-burn-cream-and-first-aid-kits-by-gfa-production-xiamen-co-ltd/): On December 23, 2022, GFA Production (Xiamen) Co., Ltd. initiated a voluntary nationwide recall of one lot of its Easy Care first aid AfterBurn cream after an FDA analysis found the product contaminated with the microbes Bacillus licheniformis and Bacillus sonorensis. - [FDA updates recall of select Philips Respironics Trilogy 100/200 Ventilators](https://trulaw.com/fda/fda-updates-recall-of-select-philips-respironics-trilogy-100-200-ventilators/): On December 22, 2022, the FDA issued new information concerning a number of Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators it had recalled in June 2021.  - [FDA alerts to lot withdrawals of ALK-Abelló, Inc.’s Allergenic Extract – Peanut (Arachis hypoagaea) – For Diagnostic Use Only](https://trulaw.com/fda/fda-alerts-to-lot-withdrawals-of-alk-abello-inc-s-allergenic-extract-peanut-arachis-hypoagaea-for-diagnostic-use-only/): Due to a spike in reports of false negative test results, the manufacturer ALK-Abelló, Inc. has voluntarily withdrawn four lots of Allergenic Extract - Peanut (Arachis hypogaea) - For Diagnostic Use Only, the FDA announced on December 20, 2022.  - [FDA Warns–Class I recall of Clearlink Basic Solution Set with Duovent by Baxter Healthcare Corporation](https://trulaw.com/fda/fda-warns-class-i-recall-of-clearlink-basic-solution-set-with-duovent-by-baxter-healthcare-corporation/): A recall of Baxter Healthcare Corporation’s Clearlink Basic Solution Set with Duovent, initiated by the firm on August 9, 2022, has been labeled by the FDA as Class I, the most serious type. This designation indicates that use of the product may lead to serious injuries or death.  - [FDA Warns–Class I recall of Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps](https://trulaw.com/fda/fda-warns-class-i-recall-of-arrow-autocat-2-ac3-intra-aortic-balloon-pumps/): An October 17, 2022 recall of the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps by Arrow International, LLC (a subsidiary of Teleflex) has been identified by the FDA as Class I, the most serious category.  - [FDA Warns – Class I recall of Arrow MAC Two-Lumen Central Venous Access, Pressure Injectable Arrowg+ard Blue Plus Three Lumen Central Venous Catheter (CVC) Kits](https://trulaw.com/fda/fda-warns-class-i-recall-of-arrow-mac-two-lumen-central-venous-access-pressure-injectable-arrowgard-blue-plus-three-lumen-central-venous-catheter-cvc-kits/): Due to a risk of serious injuries or death, the FDA has identified a Class I recall of the Arrow MAC Two-Lumen Central Venous Access Kits and the Pressure Injectable Arrowg+ard Blue Plus Three Lumen Central Venous Catheter (CVC) Kits by Teleflex and Arrow International, LLC.  - [FDA Warns – Aurobindo Pharma USA recalls of 2 lots of Quinapril and Hydrochlorothiazide Tablets USP](https://trulaw.com/fda/fda-warns-aurobindo-pharma-usa-recalls-of-2-lots-of-quinapril-and-hydrochlorothiazide-tablets-usp/): Two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg by Aurobindo Pharma USA, Inc. were put under voluntary recall, according to an October 24, 2022 press release. - [Marine veterans, families sue U.S. government for harm traced to toxic water at Camp Lejeune](https://trulaw.com/fda/marine-veterans-families-sue-u-s-government-for-harm-traced-to-toxic-water-at-camp-lejeune/): In a major mass litigation, 14,000 claims have been filed after the Camp Lejeune Justice Act was passed into law this past August. - [FDA urges healthcare providers to provide clear instructions for self-collecting anterior nares sample](https://trulaw.com/fda/fda-urges-healthcare-providers-to-provide-clear-instructions-for-self-collecting-anterior-nares-sample/): In a letter posted to its site on October 7, 2020, the FDA asked healthcare providers to institute a set of precise instructions to patients collecting their anterior nares (nasal) sample in a healthcare setting for SARS-CoV-2 testing. The agency outlined its recommendations out of concern patients may not be collecting sound test samples, thereby limiting the sensitivity and accuracy of the tests. - [FDA alerts to urgent recall of Penumbra’s JET 7 Catheter with Xtra Flex Technology](https://trulaw.com/fda/fda-alerts-to-urgent-recall-of-penumbras-jet-7-catheter-with-xtra-flex-technology/): The FDA continues to ensure healthcare providers are aware of an urgent recall of the JET 7 Reperfusion Catheter with Xtra Flex Technology (also known as JET 7 Xtra Flex) by Penumbra. - [FDA highlights voluntary recall of 3 lots of Detect Covid-19 Tests](https://trulaw.com/fda/fda-highlights-voluntary-recall-of-3-lots-of-detect-covid-19-tests/): Three lots of Detect Covid-19 Tests by Detect, Inc. have been voluntarily recalled; the FDA announced on its site Monday, December 12, 2022. The firm communicated the recall four days prior and it was initiated after an internal investigation revealed that tests in the lots could produce false negative results. - [FDA Warns – Class I recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate by Remel, Inc](https://trulaw.com/fda/fda-warns-class-i-recall-of-thermo-scientific-gram-negative-ivd-ast-sensititre-plate-by-remel-inc/): Following an October 25, 2022 Urgent Medical Device Correction issued by Remel, Inc, the FDA has identified a Class I recall of the firm’s Thermo Scientific Gram Negative IVD AST Sensititre Plate. - [FDA Warns – Class I recall of DNA/RNA Preservation Kits by Dewei Medical Equipment Co.](https://trulaw.com/fda/fda-warns-class-i-recall-of-dna-rna-preservation-kits-by-dewei-medical-equipment-co/): The FDA is calling to attention the Class I recall of DNA/RNA Preservation Kits by Dewei Medical Equipment Co. The recall, initiated by the firm on August 19, 2022, came after the products were found to have been distributed to U.S. customers without FDA authorization, clearance, or approval. - [FDA warns of potential methanol contamination in hand sanitizer by Adam’s Polishes, LLC](https://trulaw.com/fda/fda-warns-of-potential-methanol-contamination-in-hand-sanitizer-by-adams-polishes-llc/): On November 7, 2022, the FDA alerted the public of a voluntary recall of 20 lots of Adam’s Polishes Hand Sanitizer after FDA testing detected undeclared methanol in a single lot. In an announcement posted to its site, the company said it recalled the additional 19 lots out of “an abundance of caution.” - [FDA Warns – Class I recall of Omnipod DASH Insulin Management System PDM by Insulet](https://trulaw.com/fda/fda-warns-class-i-recall-of-omnipod-dash-insulin-management-system-pdm-by-insulet/): On November 4, 2022, the FDA alerted the public to a Medical Device Correction announced on October 17, 2022, by Insulet Corporation regarding all of the company’s Omnipod DASH Person Diabetes Managers (PDMs). - [FDA highlights potential problems, risks with MitraClip device by Abbott](https://trulaw.com/fda/fda-highlights-potential-problems-risks-with-mitraclip-device-by-abbott/): On September 8, 2022, the FDA warned healthcare providers of possible clip-lock malfunctions posed by the Abbott MitraClip Clip Delivery Systems. The alert was sent out in parallel with the company’s communication dated the same day. - [FDA alerts to shortage of Getinge Maquet/Datascope IABP devices](https://trulaw.com/fda/fda-alerts-to-shortage-of-getinge-maquet-datascope-iabp-devices/): As of December 2, 2022, Getinge Maquet/Datascope Intra-Aortic Balloon Bump (IABP) devices were added to the FDA’s medical device shortage list as officials worked to inform healthcare facilities and providers. The shortage, first called to attention by Getinge on November 29, 2022, points to “limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABSP parts.” - [FDA alerts users to nationwide recall of sodium bicarbonate injection by Excela Pharma Sciences, LLC](https://trulaw.com/fda/fda-alerts-users-to-nationwide-recall-of-sodium-bicarbonate-injection-by-excela-pharma-sciences-llc/): As a public service, the FDA is calling to attention a voluntary nationwide recall of select lots of sodium bicarbonate injection produced by Excela Pharma Sciences, LLC. The company announcement, made on October 12, 2022, and posted to the FDA’s website on October 13, 2022, initially alerted consumers to the recall of 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. - [FDA revises guidance on uses of at-home COVID-19 antigen tests](https://trulaw.com/fda/fda-revises-guidance-on-uses-of-at-home-covid-19-antigen-tests/): As of November 1, 2002, the FDA has updated its recommended uses and required labeling of authorized COVID-19 antigen tests as a measure against possible false negative results. This new guidance emphasizes repeat testing, or serial testing, over a prolonged period in an effort to reduce the risk that the test does not detect the infection and unknowingly spreads to others. - [FDA Warns – Teleflex Inc. Recalls Bacterial, Viral Filters for Respiratory Equipment](https://trulaw.com/fda/fda-warns-teleflex-inc-recalls-bacterial-viral-filters-for-respiratory-equipment/): Pennsylvania-based medical technologies provider, Teleflex Inc., recalled over 60,000 respirator filters after receiving dozens of reports that they were splitting or detaching while in use. - [FDA Investigates – Prolia Poses Dangerous Risks of Hypocalcemia in Dialysis Patients](https://trulaw.com/fda/fda-investigates-prolia-poses-dangerous-risks-of-hypocalcemia-in-dialysis-patients/): The FDA is looking into the correlation between the use of osteoporosis medication Prolia and severe hypocalcemia in patients treating their advanced kidney disease with dialysis. . - [FDA Warns Against the Use of Infant Head-Shaping Pillows](https://trulaw.com/fda/fda-warns-against-the-use-of-infant-head-shaping-pillows/): The FDA recently warned parents, caregivers, and healthcare providers about using infant head-shaping pillows that claim to treat or prevent medical conditions. - [FDA Warns – Class I Recall Issued for Baxter Hillrom WatchCare IMS](https://trulaw.com/fda/fda-warns-class-i-recall-issued-for-baxter-hillrom-watchcare-ims/): Baxter Hillrom is recalling their Incontinence Management System after reports that the radiofrequency emissions form the device could interfere with other vital medical equipment. - [FDA Warns – Certain Whele, LLC Heating Pads Recalled Due To Risk of Shock, Burn Injuries](https://trulaw.com/fda/fda-warns-certain-whele-llc-heating-pads-recalled-due-to-risk-of-shock-burn-injuries/): Boston-based Whele, LLC voluntarily recalled more than 500,000 of their Mighty Bliss Electric Heating Pad units after receiving numerous product safety concerns from consumers. - [FDA Warns – New Issues Arise in Previously Recalled Philips Respironics Ventilators](https://trulaw.com/fda/fda-warns-new-issues-arise-in-previously-recalled-philips-respironics-ventilators/): The FDA recently requested additional details on a number of Philips Respironics Trilogy Ventilators that are experiencing new potential issues after they were reworked as part of a June 2021 recall. - [Diocto Liquid, Subject of Stool Softener Lawsuit, Blamed for Infant Deaths ](https://trulaw.com/fda/diocto-liquid-infant-death-warning/): PharmaTech LLC, the maker of “Diocto Liquid,” an oral liquid stool softener, is facing allegations that the drug was contaminated with Burkholderia cepacia (B cepacia), a rare complex of bacteria that can cause life-threatening infections in those with lung disease, compromised immune systems, and chronic lung infections that are often resistant to common antibiotics. - [FDA Warns – Xeljanz Label Updated To Include Serious Risks](https://trulaw.com/fda/warning-xeljanz-use-serious-risks/): The U.S. Food and Drug Administration (FDA) approved Xeljanz and Xeljanz XR on November 6, 2012, and February 23, 2016, respectively. Both drugs are made by Pfizer, Inc. and were approved to treat moderate to severe active rheumatoid arthritis. - [FDA Warns Excessive Ocaliva Dosage Could Lead to Serious Liver Injury](https://trulaw.com/fda/warning-ocaliva-serious-liver-injury/): The U.S. Food and Drug Administration (FDA) approved Ocaliva (obeticholic acid) on May 31, 2016, to treat primary biliary cholangitis (PBC), a chronic liver condition resulting from destruction of the bile ducts in the liver. When the bile ducts are impaired, bile builds up in the liver, leading to inflammation and scarring, which can result in cirrhosis and impairment of liver function. - [FDA Warns Trulicity May Lead to Anaphylactic Reactions, Anaphylaxis, and Angioedema](https://trulaw.com/fda/trulicity-anaphylactic-reactions/): The U.S. Food and Drug Administration (FDA) approved Trulicity, a type 2 diabetes drug manufactured by Eli Lilly & Company, on September 18, 2014. The drug in combination with diet and exercise is intended to improve glycemic control in adults with type 2 diabetes mellitus. - [FDA Warns Qvar Use Could Lead to Blurred Vision, Central Serous Chorioretinopathy](https://trulaw.com/fda/qvar-blurred-vision-centralserouschorioretinopathy/): The U.S. Food and Drug Administration (FDA) approved Qvar (beclomethasone dipropionate hfa) on September 15, 2000, for the treatment of asthma. Qvar is a steroid manufactured by Teva Pharmaceutical Industries, Ltd. that works directly in the lungs to ease breathing by reducing the irritation and swelling of the airways is used to prevent an asthma attack, but will not treat an asthma attack that has already begun. - [FDA Warns Latuda Use Could Lead to Hyponatremia](https://trulaw.com/fda/warning-latuda-use-hyponatremia/): The FDA warns that Latuda, a drug used to treat major depressive episodes, could lead to a serious condition called hyponatremia which occurs when water and sodium are out of balance in the body. - [FDA Warns Marinol Use May Lead to Number of Serious Adverse Effects ](https://trulaw.com/fda/warning-marinol-serious-adverse-events/): The U.S. Food and Drug Administration (FDA) approved Marinol (dronabinol) on May 31, 1985, for the treatment of anorexia nervosa associated with weight loss in patients with AIDS, and chemotherapy-induced nausea and vomiting (CINV). - [FDA Warns Victoza (liraglutide) Could Cause Acute Gallbladder Disease](https://trulaw.com/fda/victoza-acute-gallbladder-disease/): Victoza is an injectable drug that was approved on January 25, 2010, to treat type 2 diabetes mellitus. - [FDA Warns – Ofev (nintedanib) May Cause Drug-Induced Liver Injury, Hyperbilirubinemia, And Jaundice](https://trulaw.com/fda/ofev-drug-induced-liver-injury-jaundice/): The U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) capsules for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. - [FDA Warns Epinephrine Use Can Lead to Stress Cardiomyopathy](https://trulaw.com/fda/warning-epinephrine-stress-cardiomyopathy/): Epinephrine was approved on May 23, 1984, to treat cardiac arrest and anaphylaxis. Endo International and GeoPharma, Inc manufacture the drug. - [FDA Warns Carafate (sucralfate) May Cause Pulmonary & Cerebral Emboli](https://trulaw.com/fda/carafate-sucralfate-pulmonary-cerebral-emboli/): The FDA approved Carafate (sucralfate) in 1981 for the short-term treatment of active duodenal ulcers. A duodenal ulcer is a sore on the upper part of the small intestine and is very common with more than 200,000 cases in the U.S. every year. - [FDA Warns Cholesterol Lowering Statin Drugs Can Cause Interstitial Lung Disease](https://trulaw.com/fda/statin-drugs-interstitial-lung-disease-warning/): Statin drugs lower the level of cholesterol in the blood by decreasing the production of cholesterol by the liver. Statins work by blocking hydroxy-methylglutaryl-coenzyme A reductase (HMG-CoA reductase), the enzyme in the liver that is responsible for producing cholesterol. - [Tanzeum (albiglutide) Discontinued After FDA Warns Of Risk Of Anaphylaxis Reaction](https://trulaw.com/fda/tanzeum-albiglutide-anaphylaxis-reaction/): Tanzeum (albiglutide) is an injectable diabetes medication that was approved by the U.S. Food and Drug Administration (FDA) in 2014. A glucagon-like peptide (GLP-1) receptor agonist, Tanzeum is used, along with diet and exercise, to help control blood sugar levels in those with type 2 diabetes, and is typically prescribed after other diabetes medications have been unsuccessful.