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FDA Will Not Recall Metformin in the U.S.

In December we reported that the FDA was testing the common diabetes drug metformin for dangerous levels of a carcinogen. Good news from the FDA: after testing, metformin is not being recalled. The FDA tests in the U.S. Concluded that the levels of NDMA were “not detectable to low.”

The FDA conducted tests to see if metformin contained NDMA in levels that would be dangerous. The popular heartburn medication Zantac (ranitidine) was recalled for containing the same carcinogen in September. In addition, common blood pressure medications angiotensin II receptor blockers (ARBs) were recalled in several countries due to containing NDMA. 

The FDA will keep metformin and other drugs on its radar for dangerous levels of NDMA and other cancer-causing contaminants. 

What is NDMA?

NDMA can form during the process of making, packaging, and storing a drug in an industrial facility. It is called a genotoxic substance because it can harm the genetic material in a cell, and, over time, increase cancer risk. It can be found naturally in small amounts in cured foods, smoked meats, beer, and tobacco smoke. 

NDMA is safe in levels below 96 nanograms daily, but amounts higher than that are dangerous.

The European Medicines Agency has not detected dangerous levels in metformin in the EU. However, in Singapore, three versions of metformin were recalled due to high NDMA levels.


About metformin

Metformin is the fourth most-prescribed drug in the U.S. Over 120 million people around the world have been prescribed the drug for diabetes, but can also help with many other conditions, such as obesity, polycystic ovary syndrome, and more.  

The drug, also known as glucophage, helps people with diabetes manage their blood sugar levels. It does this by inhibiting glucose production in the liver, and reducing the amount of sugar the body produces and absorbs.

In addition, metformin increases insulin sensitivity. The drug works best as part of a larger health regimen in which the person with diabetes follows a healthy eating plan and exercises regularly.

Metformin interactions

Metformin may interact with medications for:

  • Blood pressure 
  • Cholesterol 
  • Glaucoma 
  • Digestion 
  • Hormone replacement therapy
  • Tuberculosis 
  • Thyroid problems

Metformin may also interact with some vitamins and supplements meant to decrease blood sugar. If you take medications for any of these conditions, talk with your doctor or pharmacist about possible interactions with the drugs.

Do not stop taking metformin without talking to your doctor. If you encounter a problem while taking metformin or any other drug, report it to the FDA at their MedWatch page.