Nostrum Laboratories Recalls Metformin Pills Issued After High Levels of NDMA Detected

High levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA) have led to another recall for metformin pills, impacting two lots of the extended release version of the generic diabetes drug sold by Nostrum Laboratories.

The FDA announced the Metformin HCI Extended Release Tablets recall on November 2, after testing found levels of NDMA that exceeded the agency’s acceptable daily intake limit of 96 nanograms (ng) per day.

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 Nostrum Laboratories’ Metformin HCI Extended Release Tablets, USP 750 mg, with an NDC number of 29033-056-01, and lot numbers MET200101 and MET200301. Both have an expiry date of 05/2022.

The recalled tablets were packaged in bottles of 100 and distributed to wholesalers nationwide.

The drug manufacturer indicates it is notifying its distributors by letter and arranging for the return of the recalled metformin tablets. It recommends that consumers consult a healthcare professional to obtain replacements or use a different treatment letter.

Consumers with medical questions about the recall can call Nostrum Laboratories, Inc. Medical Affairs at 816-308-4941 or send an email to quality@nostrumpharma.com.

Metformin Recall 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 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 as specific lots of the medication have been found to contain higher than acceptable levels of NDMA.

Since the metformin recalls began, a number of consumers have filed NDMA 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.