Voluntary Recall for Metformin Hydrochloride Extended-Release Tablets

  • July 2, 2020

    On May 28, 2020, The U.S. Food and Drug Administration (FDA) announced a voluntary recall by Apotex Corporation for all batches (lot number) of metformin hydrochloride extended release (ER) 500 mg tablets made by their company. The FDA found that one batch of metformin hydrochloride ER made by Apotex contained low levels of NDMA. The impacted NDC is 60505-0260-1.

    On June 1, 2020, The U.S. Food and Drug Administration recalled all lots of metformin (500mg and 750mg) tablets made by Amneal Pharmaceuticals LLC. The recall is also due to detected low levels of NDMA.

    Members have been asked to contact the pharmacist who dispensed their medication or the provider who prescribed their medication if their medicine is included in this recall. Their pharmacist may dispense another metformin product not affected by this recall and a new prescription isn’t required. Their provider may prescribe an alternative treatment option.

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