FDA Warning & Recall Information

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. […]

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. Originally issued on May 10, 2022, the […]

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. Disposable and intended for use with CADD infusion pumps, the CADD Administration […]

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. A press release on February 3, 2023, indicates the company took action after environmental sampling in its facilities […]

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. The company announced the action on February 2, 2023, after the FDA was notified by the Centers […]

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. The action was initiated on February 1, 2023, after the company […]

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. The FDA initiated the action on August 2, 2022, and impacts masks […]

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. The action was initiated on January 26, 2023, after the Oregon Department of Agriculture, by […]

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. On January 27, 2023, Edgewell Personal Care announced another batch […]

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. Designed to be an easily-opened packet, the Emergent RSDL […]