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# Impurity Concerns Spread to Metformin Generics
- URL: https://www.fdaweb.com/impurity-concerns-spread-to-metformin-generics/
- Published: 2019-12-09T12:00:00.000Z
- Updated: 2026-09-14T15:55:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145676

FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now spread to some metformin diabetes medicines after other countries reported low levels of the nitrosamine N-Nitrosodimethylamine (NDMA). “Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water,” CDER director **Janet Woodcock** says in a statement. “While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time.”

Woodcock notes that the agency is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. “The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found,” she says. “If as part of our investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.”