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What You Need to Know About the Metformin Recall

Date Posted: Monday, June 01, 2020

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The U.S. Food and Drug Administration (FDA) has asked five pharmaceutical companies to voluntarily recall metformin, which is frequently prescribed to manage type 2 diabetes.

The limited recall of metformin extended-release (ER) tablets 500 mg from some U.S. manufacturers, is the result of a recent series of tests that revealed high levels of N-nitrosodimethylamine (NDMA), which is believed to cause cancer in people. 

FDA testing has not shown NDMA in immediate release (IR) metformin products, which is the most commonly prescribed type of metformin. 

“The recall only applies to some of the extended release metformin pills on the market,” says Dr. Michael Thompson, ambulatory physician leader and chief of adult diabetes clinical research at the UMass Memorial Diabetes Center of Excellence (DCOE). “Metformin itself is an extremely safe medication.” 

Anyone taking metformin ER 500 mg tablets is encouraged to contact their pharmacist or mail order supplier to determine if it’s from one of the manufacturers involved in the recall. 

“If your metformin ER comes from a manufacturer whose product has not been recalled, continue taking the medication as prescribed,” added Dr. Thompson.

The FDA recommends continuing metformin, even if recalled, until a replacement is prescribed. Stopping the medication immediately could lead to dangerous health risks. Recall notices are posted on the FDA website.

If your metformin ER is from one of the manufacturers affected by the limited recall, your pharmacy should be able to replace your supply with tablets from a non-affected manufacturer. 

"Now that we have identified some metformin products that do not meet our standards, we're taking action," according to Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research. "We will communicate as new scientific information becomes available and will take further action, if appropriate."

If you have questions for your UMass Memorial DCOE physician or care team about alternative medications, the best way to contact us is through myChart. You can reach the DCOE clinic during regular business hours at (508) 334-3206.

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