Official Statement

American Diabetes Association® Echoes FDA Statement on Metformin Recall

June 19, 2020 | Arlington, Virginia

Consumers should first check with their pharmacist to see if their metformin prescription is affected

The U.S. Food and Drug Administration (FDA) recently announced a recall on extended-release (ER) metformin drugs from five manufacturers due to testing results showing N-Nitrosodimethylamine (NDMA) above the acceptable intake limit in certain lots. Type 2 diabetes patients who are currently taking an ER version of metformin and are unsure if their medication is affected, should first check with their pharmacist to see if their prescribed medication is one of the five being recalled:

  • Apotex – All lots
  • Amneal – All lots
  • Marksans (labeled as Time-Cap) – One lot (XP9004)
  • Lupin – One lot (G901203)
  • Teva (labeled as Actavis) – 14 lots

Currently, only the manufacturer lots mentioned above are affected. There are several metformin manufacturers whose products are not being recalled at this time. “Patients should continue to take their metformin until their pharmacist supplies a different manufacturer’s product or their doctor prescribes a different treatment,” said Matt Petersen, Vice President, Medical Information and Professional Engagement for the American Diabetes Association. “Medications should not be stopped unless directed to do so by their doctor.”

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About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).