Amneal Pharmaceuticals (Bridgewater, NJ) announced on May 29, 2020 that it is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of above FDA-acceptable amounts of N-Nitrosodimethylamine (NDMA) detected in the product. The recall was initiated after FDA notified the company that testing of seven lots of the product found above-acceptable NDMA impurity levels and recommended the product be recalled. The company has extended the recall to all lots within expiry “out of an abundance of caution.”
