NDMA Problems Leads To Additional Metformin Recalls

Problems with N-nitrosodimethylamine (NDMA) contamination has resulted in another metformin recall, impacting additional versions of the generic diabetes drug sold by Nostrum Laboratories, which may contain dangerous levels of the toxic chemical byproduct.

The FDA announced a Metformin HCI Extended Release Tablets recall expansion on January 25, indicating Nostrum Laboratories, Inc. had discovered another lot of its generic diabetes drug tablets contained levels of NDMA which exceeded the acceptable daily intake limit of 96 nanograms (ng) per day. It is the second expansion of the Nostrum NDMA metformin recall, which was first announced in November.

NDMA is considered a human carcinogen, which can be a byproduct of the drug manufacturing process or produced as an inherent byproduct of 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.

The recall affects Metformin HCI Extended Release Tablets, USP 750 mg, with NDC 29033-056-01 and lot number MET200601, with expiry dates 07/2022. The recalled tablets are off-white and oblong, debossed with “NM7”.

Nostrum Laboratories, Inc. indicates it will notify distributors by letter, and is arranging for the return of all of the recalled products, according to the recall notice.

Metformin NDMA Recalls

This action marks 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.