FDA alerts patients and health care professionals to two voluntary recalls of metformin ER - Drug Information Update

Laboratory Tests | Metformin | FDA

Marksans Pharma and Sun Pharmaceutical Industries Voluntarily Recall Extended Release (ER) Metformin

FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical Industries. The companies are recalling metformin because it may contain N-nitrosodimethylamine (NDMA) above the acceptable intake limit. Marksans expanded its voluntary recall to include 76 additional unexpired lots of metformin ER tablets (500 mg and 750mg) labeled as Time-Cap Labs. Sun voluntarily recalled one lot of Riomet ER, metformin hydrochloride for extended release oral suspension (500 mg per 5 mL). 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. The agency’s testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).