FDA MedWatch - Metformin HCl Extended Release Tablets - USP, 750 mg by Nostrum Laboratories: Recall - Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Metformin HCl Extended Release Tablets - USP, 750 mg by Nostrum Laboratories: Recall - Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit  AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: Nostrum Laboratories, Inc. is recalling one lot of Metformin HCl Extended Release Tablets - USP, 750 mg (generic equivalent to Glucophage Tablets) because the tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. This is an expansion of the recall initially announced on November 2, 2020. NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall. For product description, NDC, lot number and expiration dates, click the red button "Read Recall" below. BACKGROUND: Metformin HCl Extended Release Tablets are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. RECOMMENDATION:  Pharmacies that have Metformin HCl Extended Release Tablets - USP, 750 mg (generic equivalent to Glucophage Tablets) which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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