Zantac recalled from U.S., Canada amid concerns over cancer-causing substance

The brand-name heartburn drug will be recalled amid FDA and company investigations into contamination.

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By Reuters and Bianca Seidman

Popular heartburn drug Zantac is being recalled across the U.S. and Canada by manufacturer Sanofi SA, amid health agency investigations into a cancer-causing impurity found in recent tests.

The French company announced the voluntary recall of the brand-name product as it works with the U.S. Food and Drug Administration and European regulators to determine the extent of the contamination with a substance called N-nitrosodimethylamine (NDMA).

Generic manufacturers of the heartburn drug ranitidine, commonly sold as Zantac, had previously halted distribution of the drug. Pharmacy chains including Walmart, CVS, Walgreens and Rite Aid have suspended the sale of over-the-counter heartburn medications containing the drug.

The U.S. Food and Drug Administration said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.

Canada has requested drugmakers halt distribution of the drug while it gathers more information.

Last month, U.S. and European health regulators said they were reviewing the safety of all ranitidine products after an online pharmacy called Valisure notified them that it had found impurities in the drugs.

Sanofi has sold over-the-counter Zantac in the U.S. and Canada since 2017. The company said it sources ingredients for Zantac sold in the U.S. and Canada from different suppliers than it uses for Zantac sold in other countries.

Sanofi CEO Paul Hudson, speaking at a press conference in Framingham, Mass., earlier this week, downplayed concerns about the drug.

"We don't believe there's a risk," Hudson said on Tuesday. "But we have to — and are appropriately duty bound to — satisfy the regulators, which we will do, and we'll move on from there."

Ranitidine is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year.

Reporting by Michael Erman for Reuters, Bianca Seidman for TODAY.