At the recommendation of the U.S. Food and Drug Administration (FDA), five drug makers have voluntarily recalled their brands of metformin, a type 2 diabetes medication that is used to control blood sugar levels. The companies include:
- Apotex Corp., which recalled its extended-release metformin in May, after the FDA found NDMA contamination in one lot of its medication. Apotex eventually recalled all supplies in the drug “out of an abundance of caution,” according to the company.
- Teva Pharmaceuticals USA recently announced a voluntary recall of 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1,000 count bottles, in the U.S.
- India-based Marksans Pharma Limited also voluntarily recalled its Metformin Hydrochloride Extended-Release Tablets USP 500 mg, lot #XP9004, which were being distributed in the U.S. by Time-Cap Labs of Farmingdale, New York.
Brand name varieties of metformin include Glucophage, Glucophage XR, Fortamet, and Glumetza.
Metformin is considered to be a safe, inexpensive, and effective drug for the treatment of type 2 diabetes. It is one of the most common prescription medications in the U.S. and is widely accessible in other countries as well.
Why is Metformin Being Recalled?
According to the FDA, tests had concluded that several batches of the drug contained unsafe levels of N-Nitrosodimethylamine (NDMA), a chemical that triggered similar recalls of the heartburn medication Zantac (an angiotensin II receptor blocker) last year. Over time, overexposure to NDMA is thought to increase a person’s cancer risk.
The FDA has found that some metformin medications distributed in other countries were reported to contain low levels of NDMA. According to the FDA investigation, metformin sold in the U.S. market also contains NDMA above the acceptable daily intake limit of 96 nanograms. Due to its findings, the FDA contacted the companies to urge voluntary recall of their products.
The recall only applies to ER metformin and does not include immediate-release medications.