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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL
Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL (Posted 2 days ago)

The U.S. District Judge presiding over all Suboxone lawsuits has created a mentorship program to use the litigation to provide some attorneys an opportunity to gain experience in handling complex federal multidistrict litigations.

Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M
Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M (Posted 4 days ago)

Gilead says it will pay $40 million to resolve HIV drug lawsuits over Truvada, Atripla, Viread, Stribild and Complera pending in the federal court system, involving claims that the the company sat on safer formulations of the drugs for years to increase profits.