Apotex Recalled Metformin Extended Release Tablets Due to Contamination With Cancer-Causing Chemicals

Federal regulators have announced the first of what may be many metformin recalls in the coming days, after discovering that batches of the first-line diabetes drug sold by different manufacturers may excessive levels of a cancer-causing chemical.

An Apotex Metformin Hydrochloride Extended Release recall was announced by the FDA on May 28, impacting 500mg tablets of the diabetes drug distributed prior to February 2019.

Apotex recalled the Metformin pills only days after the FDA issued an alert, warning that some metformin may contain high levels of N-Nitrosodimethylamine (NDMA).

NDMA is considered a human carcinogen, which can be a byproduct of the drug manufacturing process or from inherent processes associated with 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.

According to this latest recall announcement, Apotex Corp. is recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, which have not yet expired. The recall came after testing showed that levels of NDMA in one lot exceeded the FDA’s Acceptable Daily Intake Limit of 96 nanograms per day.

The recalled metformin tablets were distributed nationwide in 100 count bottles and have an NDC number of 60505-0260-1. Apotex indicates it stopped selling this metformin product in the U.S. in February 2019, but said limited products still remain on the market.

The FDA warning last week indicated that it is likely a stream of similar metformin recalls is on the way and is concerned the recalls may lead to a metformin shortage.

Metformin NDMA Concerns

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 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 2020, 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.

Now, the FDA says it has confirmed some of the Valisure findings, indicating it agrees some, but not all, of the lots Valisure raised concerns about contained excessive levels of NDMA.

The agency recommends patients keep taking their metformin, even if it is subject to a recall, until they can talk to their doctor about a suitable replacement.

The FDA is also calling on drug manufacturers who make metformin containing extended release products to evaluate whether they contain excessive levels of NDMA. The warning indicates future recalls, and further information, will be posted on its website as more data becomes available.

Those with products affected by the latest recall can call Inmar Rx Solutions at 1-888-985-9014 to arrange for their return, and customers with questions can call Apotex Corp. at 1-800-706-5575 or send an email to UScustomerservice@Apotex.com.