Sponsored By

Over-the-counter Zantac recalled in U.S. and Canada

Drug maker Sanofi says move is precautionary pending investigation

Russell Redman

October 18, 2019

3 Min Read
ZantackRecall.jpg
Yichuan Cao/NurPhoto via Getty Images

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.”

Related:Retailers halt sale of Zantac, ranitidine OTC medicines

Sanofi Zantac products - Copy.jpg

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.

Related:Price Chopper hooks up with health information exchange

“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.”

Read more about:

Rite Aid

About the Author

Russell Redman

Senior Editor
Supermarket News

Russell Redman has served as senior editor at Supermarket News since April 2018, his second tour with the publication. In his current role, he handles daily news coverage for the SN website and contributes news and features for the print magazine, as well as participates in special projects, podcasts and webinars and attends industry events. Russ joined SN from Racher Press Inc.’s Chain Drug Review and Mass Market Retailers magazines, where he served as desk/online editor for more than nine years, covering the food/drug/mass retail sector. 

Russell Redman’s more than 30 years of experience in journalism span a range of editorial manager, editor, reporter/writer and digital roles at a variety of publications and websites covering a breadth of industries, including retailing, pharmacy/health care, IT, digital home, financial technology, financial services, real estate/commercial property, pro audio/video and film. He started his career in 1989 as a local news reporter and editor, covering community news and politics in Long Island, N.Y. His background also includes an earlier stint at Supermarket News as center store editor and then financial editor in the mid-1990s. Russ holds a B.A. in journalism (minor in political science) from Hofstra University, where he also earned a certificate in digital/social media marketing in November 2016.

Russell Redman’s experience:

Supermarket News - Informa
Senior Editor 
April 2018 - present

Chain Drug Review/Mass Market Retailers - Racher Press
Desk/Online Editor 
Sept. 2008 - March 2018

CRN magazine - CMP Media
Managing Editor
May 2000 - June 2007

Bank Systems & Technology - Miller Freeman
Executive Editor/Managing Editor
Dec. 1996 - May 2000

Supermarket News - Fairchild Publications
Financial Editor/Associate Editor
April 1995 - Dec. 1996 

Shopping Centers Today Magazine - ICSC 
Desk Editor/Assistant Editor
Dec. 1992 - April 1995

Testa Communications
Assistant Editor/Contributing Editor (Music & Sound Retailer, Post, Producer, Sound & Communications and DJ Times magazines)
Jan. 1991 - Dec. 1992 

American Banker/Bond Buyer
Copy Editor
Oct. 1990 - Jan. 1991 

This Week newspaper - Chanry Communications
Reporter/Editor
May 1989 - July 1990

Stay up-to-date on the latest food retail news and trends
Subscribe to free eNewsletters from Supermarket News

You May Also Like