After a number of retailers suspended sales of the product, drug maker Sanofi has recalled its Zantac OTC antacid in the United States and Canada because it may contain a carcinogen.
Sanofi said Friday that it has initiated the voluntary recall “as a precautionary measure.” Last month, the Food and Drug Administration FDA issued a warning that ranitidine heartburn relief medicines — including over-the-counter Zantac — may contain low levels of the impurity nitrosodimethylamine (NDMA), a probable human carcinogen.
Sanofi, whose U.S. headquarters is in Bridgewater, N.J., said it’s working with health authorities to assess the level and extent of the recall.
“Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues,” the company said. “Active ingredients used in Sanofi's ranitidine products outside of the U.S. and Canada are sourced from different suppliers. 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.”
Retailers that have suspended sales of Zantac and private-label and/or generic ranitidine products include Walmart, Kroger, Hy-Vee and Raley’s. The nation's largest drugstore chains — CVS Pharmacy, Walgreens and Rite Aid — had previously announced they were suspending sales of some ranitidine products pending the FDA’s further investigation. The retailers said customers who purchased these medicines may return them for a refund.
Drug maker Apotex has recalled 75-mg and 150-mg generic and OTC ranitidine products sold at Rite Aid, Walgreens and Walmart, while Sandoz has issued a recall for certain lots of 150-mg and 300-mg generic ranitidine products.
Part of the H2 (histamine-2) blocker drug class, OTC ranitidine is indicated to prevent and alleviate heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease (GERD).
Global sales of nonprescription Zantac in 2018 totaled approximately $142 million, up almost 14% year over year, according to Paris-based Sanofi.
“FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. In addition, the agency has asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA in their ranitidine products and to send samples of ranitidine products to FDA to be tested by our scientists,” the FDA said in an update on its ranitidine investigation earlier this month.
“FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation,” the agency added. “To date [Oct. 2], the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”