Metformin testing finds negligible levels of nitrosamine impurity

Levels of N-nitrosodimethylamine found in metformin products ranged from not detectable to low, and there are no U.S. recalls at this time.


The FDA recently reported that no sample of metformin that it has tested exceeded the acceptable daily intake for N-nitrosodimethylamine (NDMA), a probable carcinogen.

On Feb. 3, the agency posted its laboratory results showing that the levels of NDMA in metformin products range from not detectable to low, similar to those in foods like grilled or smoked meats. The FDA has not recommended metformin recalls in the U.S.