Some metformin hydrochloride extended-release (ER) products, including brand-name Fortament and Glumetza, may contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is an environmental contaminant found in various foods and water. Concentrations of NDMA barely exceeded amounts found in common foods in preliminary tests conducted by FDA. FDA is evaluating whether these low concentrations pose a risk to patients; however, they are recommending that 5 different manufacturers voluntarily recall their metformin ER products. FDA is working with international regulatory agencies and manufacturers to identify the source of NDMA contamination, and will provide updated information when available.
Meformin is an oral antihyperglycemic medication used for improvement of glucose tolerance in patients with type 2 diabetes and is available by prescription. It helps to lower both basal and post prandial glucose levels, increases peripheral glucose utilization and insulin sensitivity. Patients taking metformin ER should discuss other treatment options with their health care provider before stopping therapy.
Patients and health care providers can report any adverse reaction related to metformin therapy to FDA's MedWatch Program in 1 of 2 ways.
- Submit a report online at www.fda.gov/medwatch/report.htm
- Complete a paper form and fax to 1-800-FDA-0178
Additional information is available at the following links:
- FDA MedWatch
- FDA Q&A on NDMA impurities in metformin products
- Manufacturer Recalls
- Apotex – Specific lot recall 500 mg ER tablets (5/27/2020), expanded to all lots (6/5/2020)
- Amneal – All lots of 500 mg and 750 mg ER tablets (5/29/2020)
- Bayshore Pharmaceuticals – Specific lots of 500 mg, 750 mg, and 1,000 mg ER tablets (8/19/2020)
- Granules – 12 specific lots of 750 mg ER tablets in 100 and 500 count bottles
- Lupin – Specific lot recall of 500 mg ER tablets (6/11/2020)
- Marksans Pharma (Time-Cap Labs, Inc) – 77 specific lots of 500 mg and 750 mg ER tablets (10/6/2020)
- Nostrum Laboratories – 2 specific lots of 500 mg ER tablets (11/3/2020) and 2 specific lots of 750 mg ER tablets (11/3/2020)
- Teva (Actavis) – Specific lots of 500 mg and 750 mg ER tablets (6/5/2020)
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