2 new recalls announced for extended-release metformin due to contamination

The FDA has announced two additional voluntary recalls of extended-release (ER) metformin, a popular medication for type 2 diabetes, due to unacceptable levels of N-nitrosodimethylamine (NDMA).

One of the recalls involves 76 unexpired lots metformin ER tablets from drug manufacturers Marksans Pharma. The other recall is focused on a single lot of metformin hydrochloride manufactured by Sun Pharmaceutical Industries.

“Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option,” according to the announcement. “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 FDA first announced the detection of high levels of NDMA, a contaminant associated with cancer, in ER metformin products back in May.

“We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” Patrizia Cavazzoni, MD, acting director of the FDA’s center for drug evaluation and research, said in a statement at the time. “Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”   

A full list of recalled ER metformin products is available on the FDA’s website.