Diabetes Drug Recalled

Teva Pharmaceuticals USA Inc is recalling 12,044 bottles of metformin hydrochloride extended-release tablets that were distributed in California. According to the March 15, 2023, US Food and Drug Administration (FDA) Enforcement Report, the tablets contain N-nitrosodimethylamine (NDMA) in excess of the acceptable daily intake limit.

The recall affects metformin hydrochloride extended-release tablets, 1000 mg, 60-count bottles (NDC 00591-2720-60), from lot 1410946A (Exp. 6/23). The tablets were manufactured by Actavis Laboratories FL Inc, Fort Lauderdale, Florida, and distributed in California by Actavis Pharma Inc, Parsippany, New Jersey.

Teva Pharmaceuticals voluntarily initiated the recall February 22, 2023. The FDA designated the recall Class II on March 7, 2023. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Metformin hydrochloride extended-release tablets are available with a prescription to help improve glycemic control in adults with type 2 diabetes mellitus.