FDA Issues Recall on Metformin ER

The FDA announced at the end of May a national voluntary recall of extended-release metformin distributed through specific manufacturers.  

At the time of their announcement, the FDA was working with several pharmaceutical companies to formally announce the recall pending which lots of the medication were affected based on distribution.

As of October 2020, one pharmaceutical company [expanded its recall][1] to include additional lots of the medication. As always, check with your health care provider to determine if you should stop taking your medication.

[1]: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin

Why was there a Metformin ER recall?

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Metformin ER, a prescription medication typically prescribed to control high blood pressure in patients is under scrutiny due to the discovery of high levels of N-Nitrosodimethylamine (NDMA). The amount of NDMA discovered in specific lots of Metformin ER formulations was above the FDA’s acceptable intake.  High levels of N-Nitrosodimethylamine can possibly cause cancer in patients.

What is NDMA?

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According to the FDA, NDMA is classified as a substance that could cause cancer, also called a carcinogen, based on results from laboratory tests. Everyone is exposed to some levels of NDMA in their everyday environment, in non-harmful levels in water and foods. However, NDMA could be harmful at high levels of exposure.

Metformin ER is not the first medication to be recalled due to high levels of NDMA. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medications since 2018. NDMA is also the contaminant responsible for the well-known heartburn medication recalls (Ranitidine and Nizatidine) that have been ongoing since 2019.

Which brand names for Metformin ER have been recalled?

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After the initial recall, which only named Amneal, the FDA alerted the public to four additional companies’ voluntary recalls of certain extended release (ER) metformin drugs. At this time, Metformin ER by the following manufacturers is being recalled:

- Apotex – All lots

- Amneal – All lots

- Markans (labeled as Time-Cap) – One lot (XP9004)

- Lupin – One lot (G9012013)

- Teva (labeled as Actavis) – 14 lots

According to the FDA, there are additional companies that manufacturer ER metformin and supply a significant portion of the U.S. market, whose products are not being recalled at this time. Check the FDA website for a continuously updated list of brand names affected by this recall.

What should I do if I am affected by the Metformin ER recall?

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The FDA urges individuals to continue to take their prescribed Metformin ER and reach out to their health care provider for specific direction based on their health. Your health care provider may prescribe a replacement medication for you, such as immediate-release (IR) Metformin which is not impacted by this recall.