Metformin Recall: The FDA Alerts Patients and Health Care Providers to Nitrosamine Impurity In Certain Metformin Products
On May 28, 2020, the U.S. Food and Drug Administration (FDA) announced that it contacted five companies to recommend that they voluntarily recall certain metformin extended-release (ER) products, a prescription drug used to control high blood sugar in patients with type 2 diabetes, because the FDA’s lab testing showed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the FDA’s acceptable limit in several lots of the extended-release (ER) formulation of metformin.
According to the FDA’s metformin recall announcement, the FDA is also asking all manufacturers of metformin containing ER products to evaluate the risk of excessive NDMA in their product and to test each batch before it is released into the U.S. market.
The FDA’s NDMA investigation began with the blood pressure and heart failure medicines called angiotensin II receptor blockers (ARBs) such as Valsartan and later expanded to include heartburn medicines, ranitidine and zantac, as well as diabetes medication, metformin and other drugs.
On May 28, 2020 the FDA announced that Apotex Corp. was voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level.
On June 1, 2020 the FDA announced that Amneal Pharmaceuticals LLC was voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.
Metformin Recall: Possible NDMA Exposure & Cancer Risk
The FDA has warned that nitrosamine impurities may increase the risk of cancer if people are exposed to NDMA contaminants at above-acceptable levels over long periods of time.
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