Diabetes Drug Recall 2020: Another Metformin Medication Recalled Over Cancer Concerns

Following a recall from Apotex Corp. for its diabetes drug Metformin because it may contain Nitrosodimethylamine (NDMA) – a cancer-causing ingredient - above the U.S. Food and Drug Administration’s (FDA) recommendations, Amneal Pharmaceuticals (AMRX) has recalled all lots of Metformin Hydrochloride Extended Release Tablets because it may also contain NDMA above the acceptable levels.

Amneal discovered the issue after the FDA tested seven lots of the drug and found NDMA above the allowable levels. NDMA is classified as a probable human carcinogen that could cause cancer. The company has not received any reports of adverse reactions related to the medication recall and said it has issued the recall “out of an abundance of caution.”

The affected Metformin medication was sold in 500 and 750 mg doses and 90, 100, 500, and 1,000 count bottles as well as in bulk boxes. The Metformin is a prescription-only drug that was sold in solid oral tablets to improve blood sugar control in adults with Type 2 diabetes mellitus. The medication was sold nationwide to wholesalers, distributors, retailers, and repackagers and was manufactured by Amneal.

The recalled diabetes medication has NDC numbers of 53746-178-01, 53746-178-05, 53746-178-10, 53746-178-90, 53746-178-Bulk, 65162-178-09, 65162-178-10, 65162-178-11, and 65162-178-50 in the 500 mg dosages and NDC numbers of 53746-179-01, 53746-179-Bulk, and 65162-179-10 in the 750 mg dosages. Labels of the recalled medication can be viewed here.

Consumers that purchased the recalled Metformin from Amneal can contact the company at 1-833-582-0812, Monday through Friday from 8 a.m. to 5 p.m. EST or by email at AmnealproductrecallDS@amneal.com for more information. Adverse reactions from the recalled Metformin can be reported to Amneal Drug Safety at 1-877-835-5472, Monday through Friday from 8 a.m. to 6 p.m. EST or by email at DrugSafety@amneal.com

Retailers t hat have the affected medication in their inventory should stop dispensing the drug and contact Inmar at 1-855-532-1851, Monday through Friday from 8 a.m. to 5 p.m. or by email at Rxcalls@inmar.com to arrange for return of the product.

The company said its Metformin Hydrochloride Immediate Release Tablets, USP are not affected by the recall.

Shares of Amneal stock were down 0.2101% as of 10:34 a.m. EDT on Tuesday.