More metformin recalled due to nitrosamine impurities

Another company recalled four lots of metformin hydrochloride extended-release tablets USP (500 and 750 mg) this month due to the detection of excess levels of N-nitrosodimethylamine, a probable carcinogen.


Following other recent recalls of extended-release metformin due to contamination with N-nitrosodimethylamine (NDMA), an additional company announced a recall of the drug.

Nostrum Laboratories Inc. recalled two lots of metformin hydrochloride extended-release tablets USP (750 mg) due to the detection of excess levels of NDMA, a probable carcinogen, according to a Nov. 2 FDA news release. The company also recalled two lots of metformin hydrochloride extended-release tablets USP (500 mg) due to NDMA contamination, the FDA announced on Nov. 3. No adverse events related to the recalls have been reported.