Viona Pharmaceuticals Metformin Recall Issued Over High Levels of NDMA Linked to Cancer Risk

The presence of cancer-causing chemicals has again led to a metformin recall, after additional lots of the generic diabetes drug were found to contain high levels of N-nitrosodimethylamine (NDMA), which exceed acceptable daily limits.

The FDA announced a Viona Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets recall on June 11, after unsafe levels of the known human carcinogen were found in some pills.

NDMA is a chemical byproduct which has plagued other manufacturers of generic metformin pills in recent years. It has also been found in a number of different generic blood pressure drugs, including valsartan, losartan and irbesartan after changes to the drug manufacturing process, and the chemical caused the massive Zantac recalls a few years after it was determined the active ingredient may convert to NDMA during storage.

The makers of Zantac and certain valsartan pills now face hundreds of lawsuits brought by former users of those medications who indicate that they developed bladder cancer, stomach cancer, testicular cancer and other injuries as the chemical passed through their bodies.

This latest recall affects two lots of Metformin Hydrochloride Extended Release Tablets, USP 750 mg, with NDC number 72578-036-01 and batch number M915601, and an expiration date of Oct-2021. The recalled tablets came in bottles of 100, and the tablets are white to off-white, capsule shaped, and uncoated. They have a debossed “Z” on one side, and “20” on the other.

The recalled tablets were distributed nationwide by Viona Pharmaceuticals, Inc. They were manufactured by Cadila Healthcare Limited in Ahmedabad, India.

Customers have been urged to contact the company to arrange for the return of recalled products. Customers with medical-related questions or quality issues can contact Viona Pharmaceuticals Inc. at 888-304-5011.

Consumers who use the pills with questions can call the recall processor Eversana Life Science Services at 888-304-5022.

Metformin NDMA Recalls

This is the latest in a series of recalls impacting generic metformin pills manufactured by a number of different companies.

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. However, the FDA indicated at the 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 recall metformin, after independent testing found levels of NDMA in certain pills was higher than the agency’s recommended daily exposure threshold of 96 nanograms.

Since then, the FDA says it has confirmed some of the Valisure findings, resulting in a number of separate recalls for metformin pills that were found to contain higher than acceptable levels of NDMA. A number of consumers have now filed metformin lawsuits against manufacturers of the generic drugs, indicating they developed cancer from the tainted diabetes medication.

The FDA requests any healthcare providers or consumers who experience adverse reactions or quality problems when using the recalled drugs report the incident to the FDA MedWatch Adverse Event Reporting program.