FDA Warning & Recall Information

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.  The action was announced on March 28, 2023, after a customer email […]

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.  The devices being evaluated include, among others:  Anterior Growth Guidance Appliance […]

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. The West Sacramento, California-based company announced the action on […]

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. The Canton, South Dakota-based company initiated the […]

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.  Manufactured from 2004 up until August 2021, many of the Exactech joint replacement devices, including those that service […]

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. Anyone with an allergy or heightened sensitivity to wheat is asked not to consume the […]

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. Those primarily impacted by this inadequate disclosure […]

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. The move was announced on March 22, 2023, after the product was found to contain a […]

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. Announced by the company on March 16, 2023, the recall impacts frozen […]

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. Based in Dubin, Ireland, the company says the voluntary recall […]

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. Described as “electromechanical systems used to inflate and deflate intra-aortic balloons,” the Cardiosave Hybrid and Rescue Intra-Aortic Balloon […]

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, […]