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# Amneal Recalls All Metformin Lots
- URL: https://www.fdaweb.com/amneal-recalls-all-metformin-lots/
- Published: 2020-06-02T12:00:00.000Z
- Updated: 2026-09-14T16:16:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146907

Amneal Pharmaceuticals is recalling all lots of metformin HCl extended-release tablets, 500 mg and 750 mg after being informed by FDA that its testing of seven lots showed N-nitrosodimethylamine amounts above acceptable FDA levels. The agency recommended a recall of the seven tested lots, according to an online [notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended?utm%5Fcampaign=Metformin%20%20N-Nitrosodimethylamine%20%28NDMA%29%20by%20Amneal&utm%5Fmedium=email&utm%5Fsource=Eloqua).

Amneal says that to date it has not received any reports of adverse events confirmed to be directly related to the recall. The company says the recall does not cover its metformin HCL immediate-release tablets. The affected extended-release tablets were distributed nationwide in the U.S. to wholesalers, distributors, retailers, and repackagers, Amneal says.