Extended-release metformin recalled due to nitrosamine impurities

A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.


More metformin is being recalled due to contamination with N-nitrosodimethylamine, a probable carcinogen.

The FDA announced on Jan. 4 that Nostrum Laboratories Inc. is recalling an additional lot of metformin hydrochloride extended-release tablets USP (750 mg) because the tablets have been found to contain levels of nitrosamine impurities above the acceptable limit. This recall is an expansion of the prior recall announced on Nov. 2, 2020.