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Metformin ER Recall Alert

June 22, 2020

On May 28, 2020, the FDA announced that laboratory testing has revealed levels of N-nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin. FDA testing has not shown NDMA in immediate release metformin products (the most commonly prescribed type of metformin).

The FDA has asked firms that manufacture metformin ER to voluntarily recall their products. To date some have, but there are still manufacturers that account for a significant portion of the market that have not done so. Recall notices will be posted to the FDA’s website.

The FDA recommends that patients continue taking metformin tablets, even after recalls occur, until they consult with their health care professional who can prescribe a replacement. Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin.

OptumRx will notify providers and members who have had prescriptions filled for metformin ER in the last 4 months.

Please visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program for the most up-to-date information regarding the recall. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

For more information, please contact your PAI representative.