Extended-release metformin recalled due to impurity

After recommending that several manufacturers recall the diabetes drug due to excess levels of N-nitrosodimethylamine, the FDA is assessing whether the recalls will result in shortages.


In the past month, several companies recalled extended-release metformin due to the detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen.

On May 27, Apotex Corp announced it was recalling all lots of metformin hydrochloride extended-release tablets USP (500 mg) due to the detection of excess levels of NDMA in one tested lot. The company stopped selling the product in the U.S. in February 2019. On May 29, Amneal Pharmaceuticals LLC also recalled all lots of metformin hydrochloride extended-release tablets (500 mg and 750 mg) due to detection of excess NDMA in seven tested lots. On June 2, Marksans Pharma Limited, India, announced a recall of one lot of metformin hydrochloride extended-release tablets USP (500 mg) due to the detection of excess levels of NDMA. Recalled products were distributed nationwide in the U.S. by Time-Cap Labs Inc. Finally, on June 2, Teva Pharmaceuticals USA Inc. announced a recall of 14 lots of metformin hydrochloride extended-release tablets USP (500 mg and 750 mg) due to the detection of excess levels of NDMA. Recalled products were distributed nationwide between Jan. 8, 2019, and May 27, 2020.

The FDA on May 28 announced that it had so far recommended voluntary recalls to five manufacturers of the extended-release formulation of metformin. “There are additional manufacturers of the metformin [extended release] formulation that supply a significant portion of the U.S. market, and their products are not being recalled,” the agency wrote in a press release. The FDA said it will assess whether the recalls will result in shortages and will work with manufacturers to ensure appropriate testing while preventing or reducing any impact of shortages.