Metformin NDMA Contamination Leads To Teva Pharmaceuticals Recall

Teva Pharmaceuticals is the latest drug manufacturer to issue a metformin recall, after federal regulators discovered many extended release versions of the diabetes treatment contain high amounts of N-nitrosodimethylamine (NDMA); a known carcinogen.

The FDA announced the Teva Metformin Hydrochloride Extended Release Tablet recall on June 5, impacting 14 lots of the first line diabetes drug.

Teva recalled the Metformin pills only days after the FDA issued an alert, warning that some metformin may contain high levels of N-Nitrosodimethylamine (NDMA). At that time, the FDA warned that major recalls were likely.

NDMA is considered a human carcinogen, which can be a byproduct of the drug manufacturing process or from inherent processes associated with certain pharmaceutical ingredients.

In recent years, detection of the chemical has resulted in widespread Zantac recalls and valsartan recalls, and users of the popular heartburn and blood pressure medications have reported developing various types of cancer following long-term use, including breast cancer, bladder cancer, stomach cancer, testicular cancer and other injuries.

This latest recall affects 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP, sold in 500 mg and 750 mg strengths in 100 and 1,000-count bottles. The 500 mg tablets are described as being white to off-white capsule shaped tablets, and have a debossed Andrx logo with “571” on one side and “500” on the other. The 750 mg tablets are light yellow capsule shaped tablets, also debossed with an Andrx logo, with “577” on one side and “750” on the other. They have expiration dates ranging from 06/2020 to 11/2021.

The pills were manufactured by Teva Pharmaceuticals USA, Inc. and sold under the Actavis label between January 8, 2019 and May 27, 2020.

Metformin NDMA Problems

In December 2019, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at that time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.

In March 2020, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to issue metformin recalls, after independent testing found levels of NDMA in certain pills was higher than the agency’s recommended daily exposure threshold of 96 nanograms.

Now, the FDA says it has confirmed some of the Valisure findings, indicating it agrees some, but not all, of the lots Valisure raised concerns about contained excessive levels of NDMA.

Teva and the FDA are recommending that patients continue taking their medication and contact their pharmacist or doctor for an alternative treatment, as it could be dangerous to stop taking metformin suddenly due to the risk of diabetes-related complications.

Customers and patients with questions can call Teva Medical Information at 888-838-2872 or via email at druginfo@tevapharm.com.