FDA Warning & Recall Information

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. Consumers are warned that […]

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 […]

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. Consumers […]

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, […]

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 […]

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. Although healthy […]

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 […]

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. To […]

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. The […]

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. […]

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 […]

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. The company had voluntarily recalled all products […]