Nostrum Laboratories, Inc., is recalling two lots of 500mg metformin HCl extended-release tablets and two lots of 750mg metformin HCl extended-release tablets because they were found to contain unsafe levels of NDMA (N-Nitrosodimethylamine), a probable human carcinogen. This is the latest drug recall over concerns about NDMA. Most notably, popular heartburn medication Zantac was recalled earlier this year.

The latest metformin recalls are among several extended-release versions of the common type 2 diabetes treatment in recent months initiated after testing revealed NDMA in levels above what the Food and Drug Administration (FDA) deems safe for daily consumption. Consumption of NDMA at higher levels may put consumers at risk for cancer, the agency cautioned.

The recall involves the following drug products:

  • Metformin HCl Extended Release Tablets, 500mg, NDC 29033-055-01, Lot number MET100201, Expiration Date 05/2022
  • Metformin HCl Extended Release Tablets, 500mg, NDC 29033-055-01, Lot number MET100401, Expiration Date 05/2022
  • Metformin HCl Extended Release Tablets, 750, NDC 29033-056-01, Lot number MET200101, Expiration Date 05/2022
  • Metformin HCl Extended Release Tablets, 750, NDC 29033-056-01, Lot number MET200301, Expiration Date 05/2022

Patients who have affected products should consult with their doctors to get a replacement or different replacement options. The FDA cautions that it could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their doctors.

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