Sanofi-Aventis Conducting Name-Brand Zantac Recall Over Contamination Worries

Published on October 21, 2019 by Sandy Liebhard

Sanofi-Aventis is recalling the name-brand, over-the-counter version of Zantac in the United States and Canada, more than a month after a potentially cancer-causing chemical was detected in samples of ranitidine-containing heartburn medications.

Sanofi has sold over-the-counter Zantac in the United States and Canada since 2017. Numerous other companies market generic versions of over-the-counter and prescription ranitidine.

Why is Zantac Being Recalled?

The U.S. Food & Drug Administration (FDA) first notified the public that some Zantac and ranitidine tablets had tested positive for the presence of N-nitrosodimethylamine (NDMA) on September 13th. The agency learned of the issue from Valisure, an online pharmacy that apparently detected the chemical in every sample of ranitidine tested, often at levels that far exceeded the maximum daily limits established by the FDA.

While the FDA has conceded that some tests found “unacceptable” levels of NDMA in ranitidine, the agency attributed those findings to Valisure’s high-temperature testing method. However, a low-temperature method favored by the FDA has also detected NDMA in ranitidine, although in lower amounts.

NDMA is considered a probable human carcinogen by the U.S. Environmental Protection Agency, as animal experiments suggests exposure may increase the risk for cancer, especially tumors of the kidney, liver, and gastrointestinal tract.

Zantac Recall Said to Be Precautionary

On Friday, Sanofi-Aventis characterized the Zantac recall as a precautionary measure, indicating it decided to act because of inconsistencies in preliminary test results.

“Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence,” the company said in a statement.

The company is continuing to work with regulators to determine the exact scope of the action.

Previous Zantac Recalls

Sanofi-Aventis is just the latest drug maker to announce a ranitidine or Zantac recall. GlaxoSmithKline, Novartis’s Sandoz subsidiary, Dr. Reddy’s Laboratories, and Apotex, have either recalled their ranitidine products or suspended sales of the drugs. Various retailers, including Walmart, Walgreens, and Rite-Aid, had already removed Zantac OTC and other ranitidine-containing heartburn drugs from store shelves.

All of these actions have been voluntary, as the FDA hasn’t actually ordered a Zantac recall. However, the agency has advised consumers who use over-the-counter versions of ranitidine to consider switching to an alternative antacid.

Those using prescription ranitidine products should not stop taking their medication without first talking to their doctor, as doing so could cause the condition being treated to worsen.

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