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Companies Recall Extended-Release Metformin due to Cancer-Causing Substance

By Nena Kotsalidis and Rosalind Lucier

The FDA announced that six companies have voluntarily recalled their extended release metformin due to the possibility that it includes unsafe levels of NDMA, a toxic substance

The FDA announced that six additional companies have recalled extended-release (ER) metformin. Earlier this year the FDA raised concerns about the safety of metformin; since then, 11 companies have voluntarily recalled the medication, due to possibly unsafe amounts of a substance called N-nitrosodimethylamine (NDMA). Low levels of NDMA are commonly found in foods and drinking water, but high levels of the substance are toxic and can cause cancer.

In early June several companies recalled ER metformin: Apotex Corp, Actavis, Amneal, and Time-Cap Labs Inc. recalled metformin hydrochloride ER tablet, USP 500 mg and 750 mg. Now, six more companies have joined the recall:

  • Granules Pharmaceuticals – 750 mg

  • Lupin Pharmaceuticals – 1000mg and 500mg

  • Avkare (a company that repackages medications for Amneal) – 500 mg and 750 mg

  • PD-Rx Pharmaceuticals (a company that repackages medications for Amneal and Marksans) – 500 mg

  • The Harvard Drug Group (a company that repackages medications for Apotex) – 500 mg

  • Preferred Pharmaceuticals (a company that repackages medications for Marksans) – 500 mg

For people taking ER metformin, the FDA recommends that you continue to take your medication until you talk to your healthcare professional. Your healthcare professional can help you find different treatment options. It is not safe to stop taking your ER metformin without instructions from your healthcare team.

This recall only applies to ER metformin. If you are currently taking immediate release (IR) metformin, you can continue to take your medication safely. The FDA has not found high NDMA levels in the more commonly prescribed immediate release (IR) metformin products.

Metformin is commonly used to help people with type 2 diabetes manage their blood sugar levels. It is considered a safe, cheap and effective medication worldwide. For more information about metformin, read our detailed piece here.

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