New Extended-Release Metformin Recall, First Since January

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New Extended-Release Metformin Recall, First Since January

A new recall of an extended-release metformin product has been announced, representing the first such announcement since January 2021, after several recalls of metformin in 2020. The latest recall was announced by the U.S. Food and Drug Administration (FDA) and applies to extended-release metformin tablets (750 milligrams) manufactured by Viona Pharmaceuticals, Inc.

As we noted early this year, metformin recalls exploded in 2020 due to concerns about a potential carcinogen (substance that causes cancer) in batches of the type 2 diabetes drug made by several different manufacturers. Metformin is one of the most widely used prescription drugs in the world, and it’s a generic drug that’s made by countless manufacturers in different doses and formulations. Because of the wide range of manufacturers, even the same dose of metformin will contain different inactive ingredients when it comes from different manufacturers, and the processes used to manufacture the drug will vary.

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Newest extended-release metformin recall

The recent concerns about a potential carcinogen in metformin actually date back to late 2019, when the FDA announced that it was investigating whether metformin products sold in the United States contained unacceptable levels of N-nitrosodimethylamine (NDMA), an impurity that can be a byproduct of drug manufacturing processes. NDMA is known to cause changes in the genetic material inside cells, which means that it may increase the risk of certain types of cancer — although it’s difficult to show a definitive link between NDMA and cancer, since there’s no practical way to measure NDMA intake from all sources over time. NDMA is also found in grilled or smoked meats, at levels that are comparable to what has been found in tests of certain prescription drugs. In 2018, the FDA set an acceptable daily intake limit for NDMA in medications of 96 nanograms. This limit is based on an estimated 1 in 100,000 risk of developing cancer after 70 years of exposure to NDMA.

For the latest recall, Viona Pharmaceuticals is attempting to notify all affected customers by mail or email to arrange for the return of the recalled metformin product. Your pharmacist may also contact you if you are affected by this recall. As with previous metformin recalls, people with the affected product are advised to continue taking it until they receive a suitable replacement product. There are no known immediate risks posed by the level of NDMA found in the recalled product, while suddenly stopping your prescribed dose of metformin could lead to a dangerous rise in blood glucose levels. There are no reports of adverse events related to the latest recall, only lab test findings that indicate a possible long-term risk from NDMA exposure.

The FDA offers a searchable online list of all recalled metformin products, in case you suspect you may have missed a previous metformin recall.

Want to learn more about metformin? Read “What to Know About Metformin,” “Diabetes Medicine: Metformin,” and “Metformin: The Unauthorized Biography.”

Living with type 2 diabetes? Check out our free type 2 e-course!

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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