FDA Warning & Recall Information

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. As of this writing, Renuvion APR Handpiece by Apyx Medical has been approved for “the delivery of radiofrequency […]

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. Though the company has not received any reports of adverse events, it recalled Batch Number H29 of the […]

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. Officials said any unpackaged […]

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. Insufficient labeling presents a […]

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. Announced on February 14, 2023, the Seattle, Washington-based company initiated the move after it found reason to believe […]

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. The action was initiated even as extensive testing confirmed the product was negative […]

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. Initiated by Magellan Diagnostics on May 28, 2021 due to a high risk of falsely low […]

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. The inadequate labeling poses a risk to people with allergies or […]

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. Indicated for use by healthcare professionals to assess […]

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. As phosphodiesterase (PDE-5) inhibitors typically present in FDA-approved male erectile dysfunction […]

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. The loss of accreditation means the facility can no longer […]

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. […]