Skip to main content

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

Editor's note: This article was updated on January 27, 2021 to reflect the latest recalls

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, thirteen companies have voluntarily recalled some or all of their ER metformin, including Nostrum Laboratories in November (see full list below). Of note, as of January 25, 2021, Nostrum Laboratories has since expanded their initial recall to include two more lots of metformin.

  • Amneal Pharmaceuticals

  • Apotex Corp

  • Avkare (repackages medications for Amneal)

  • Bayshore Pharmaceuticals

  • Granules Pharmaceuticals

  • Lupin Pharmaceuticals

  • Marksans Pharma Limited

  • Nostrum Laboratories

  • PD-Rx Pharmaceuticals (repackages medications for Amneal and Marksans)
  • Preferred Pharmaceuticals (repackages medications for Marksans)

  • Sun Pharmaceuticals

  • Teva Pharmaceuticals

  • The Harvard Drug Group (repackages medications for Apotex)

You can check to see if your metformin has been recalled here. 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.

Share this article