Class I Recall for OTC Laxative

Plastikon Healthcare is recalling three lots of Milk of Magnesia (magnesium hydroxide) oral suspension, 2400 mg/30 mL, because of microbial contamination and failure to properly investigate failed microbial testing. According to the May 25, 2022, US Food and Drug Administration (FDA) Enforcement Report, the FDA has designated the recalls Class I and Class II.

The recalls affect 30-mL cups, packaged in trays of 10 cups, 10 trays per carton (NDC 0904-6846-73), labelled for Major Pharmaceuticals. Major Pharmaceuticals distributed the Milk of Magnesia to hospitals, nursing homes, and clinics throughout the United States.

The Class I recall, which warns use of the product could cause serious adverse health consequences or death, is for Milk of Magnesia from lots 20024A and 20025A (Exp. 3/22).

The Class II recall, which warns use of the product could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm, is for Milk of Magnesia from lot 20041A (Exp. 5/22).

Plastikon Healthcare voluntarily initiated the recalls March 24, 2022. The FDA issued the recall classifications May 13, 2022.

“Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately,” Plastikon Healthcare advised in a March 24, 2022, statement. “Return all quarantined product to the place of purchase. For clinics, hospitals, or health care providers that have dispensed product to patients, please notify patients regarding the recall.”

Milk of Magnesia is an over-the-counter medication indicated for the occasional relief of constipation as well as for heartburn, upset stomach, or indigestion.