Class Action Metformin Lawsuit Filed Over Recalls Due To NDMA Contamination

Some diabetes drug makers now face a class action lawsuit, which calls for them to compensate those who purchased generic metformin that was recalled following the discovery that pills may be contaminated with a cancer-causing chemical byproduct of the manufacturing process.

Masao Hendrix filed the complaint (PDF) late last month in the U.S. District Court for the Eastern District of California, naming Avkare, Inc. and Amneal Pharmaceuticals as defendants, as well as up to 100 unnamed defendants.

Hendrix says he and other class plaintiffs paid for generic metformin products tainted with high levels of N-nitrosodimethylamine (NDMA); a known cancer causing agent. His lawsuit indicates if he and others had been told about the NDMA contamination, they would have never bought the products.

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

“At all times during the period alleged herein, Defendants represented and warranted to consumers that their generic Metformin products were otherwise fit for their ordinary uses, and were otherwise manufactured and distributed in accordance with applicable laws and regulations,” the lawsuit states. “However, for years, Defendants willfully flouted federal current Good Manufacturing Practices and ignored other warnings signs that Defendants’ Metformin products contained or likely contained NDMA and/or other impurities.”

The complaint joins a growing number of class action metformin lawsuits filed against various generic drug manufacturers in recent months. While this seeks compensation for what some plaintiffs see as wasted money spent on metformin, as well as the need for future medical monitoring, additional complaints have also been filed by individuals who claim they developed cancer following years of exposure to metformin containing the carcinogenic byproduct.

NDMA is considered a human carcinogen, and has been found to contaminate other pharmaceutical drugs to manufacturing or design problems. A number of Zantac recalls and valsartan recalls have been issued over the past few years, after dangerously high levels of NDMA were detected in the popular heartburn and blood pressure medications, and users reported developing stomach cancer, bladder cancer, liver cancer and other injuries following long-term use.

Late last year, 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, 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.


  • TimothyNovember 2, 2020 at 5:06 am

    I'm taking met phone for more than 20 years and lay health never seemed to get better only worse

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

BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal
BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal (Posted 2 days ago)

A BioZorb lawsuit has been filed by several breast cancer survivors after the BioZorb implants moved out of place and failed to dissolve int he body, requiring surgical removal.

Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October
Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October (Posted 2 days ago)

A U.S. District Court judge has scheduled a fairness hearing for October in order to determine whether final approval should be granted to a $25 million Philips CPAP recall settlement agreement, which would pay former users $25 million to pay for future medical monitoring needs.