On Dec 28, 2021 the FDA announced that Viona Pharmaceuticals (manufactured in India for US distribution) recalled 33 lots of Metformin due to NMDA contamination. The recall was for the Metformin ER 750 mg tablet, and only certain lots were affected.
This is following a similar announcement in May of 2020 that several other lots of Metformin from other manufacturers around the globe had been recalled for the same issue.
What is NMDA?
The World Health Organization classifies NDMA as a probable human carcinogen. Exposure to NDMA has been linked to several cancers and even small amounts of exposure can lead to liver damage. The U.S. Environmental Protection Agency classifies NDMA as a B2 carcinogen, meaning it has enough animal data to conclude that it’s potentially cancerous for humans as well.
Do I need to worry?
If you have concerns that you may be affected, call your pharmacy who can help identify the lot number and manufacturer of the batch you are using. If needed, your pharmacist can help you transition to a different Metformin option. There are safe extended-release formulations still available and there have been no reported contamination problems with immediate-release metformin.
Never discontinue your medication without first talking with your doctor. According to the FDA, it could be dangerous for patients to stop taking their Metformin without first talking to their healthcare professionals.