Bayshore Voluntarily Recalls Extended Release Metformin

The U.S. Food and Drug Administration (FDA) is alerting patients and health care professionals to Bayshore Pharmaceuticals’ voluntary recall of two lots of extended release (ER) metformin (one lot of 750 mg tablets and one lot of 500 mg tablets). The company is recalling metformin because it contains N-nitrosodimethylamine (NDMA) above the acceptable intake limit.

FDA publishes a recalled metformin list including details about metformin products that have been recalled. Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).