Zantac controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Virginia woman files Zantac cancer lawsuit
Lawsuit filed
In a lawsuit reported in August 2021, Deborah Haskins sued the makers of Zantac, alleging that the drug caused her esophageal cancer and that its makers failed to warn consumers of the risks. The report notes that research had not explicitly linked Zantac to cancer. The filing is presented as a claim by the plaintiff; the article does not describe a court ruling or any finding of liability.
Source excerpt
In the lawsuit, Haskins also noted that if she had known about the unsafe levels of NDMA in Zantac, she never would have purchased the medication.
The lawsuit named Sanofi, Zantac's current manufacturer in the U.S. as a defendant. It also included previous makers, Boehringer Ingelheim Pharmaceuticals and GlaxoSmithKline.
While research has not explicitly linked Zantac to cancer, the esophagus is acted upon by the drug.
2020
FDA orders Zantac sales pulled from stores
Ban or restriction
In April 2020, the U.S. Food and Drug Administration ordered that Zantac be pulled from stores effective immediately. According to the report, U.S. officials cited a cancer-causing risk associated with the medication as the reason for the action. The order applied to store sales of the product, and the article describes the removal as taking effect right away. The report does not provide further details on the specific risk, the scope of the recall, or any subsequent regulatory steps.
The FDA ordered Zantac to be pulled from stores effective immediately; the article says U.S. officials cited a cancer-causing risk associated with the medication.
Source excerpt
U.S. officials say Zantac (Ranitidine) has shown to be a risk factor in causing cancer.
the Food and Drug Administration has just ordered the product to be pulled from stores effective immediately.
2019
NDMA contamination controversy
The discovery of NDMA in some ranitidine samples led to recalls, regulatory investigations, market withdrawals, and extensive public concern about the safety of Zantac and generic ranitidine products.
2019
Zantac product-liability litigation
Patients filed lawsuits alleging that ranitidine products exposed them to NDMA and caused cancer or other injuries. The litigation involved multiple manufacturers, distributors, retailers, and brand-rights holders, with significant disputes over scientific evidence and causation.
2019
GSK announces global Zantac recall
Recall announced
GlaxoSmithKline said it was recalling prescription-only Zantac medicines in all markets as a precaution after the U.S. Food and Drug Administration found unacceptable levels of a probable cancer-causing impurity in the drug. GSK said it was also suspending the release, distribution and supply of all dose forms of Zantac products.
Company response
Recall — GSK
GlaxoSmithKline <GSK.L> on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution"
Investigation — GSK
GSK is continuing with investigations into the potential source of the NDMA
Source excerpt
GSK is continuing with investigations into the potential source of the NDMA (chemical),
Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages.
GlaxoSmithKline on Tuesday (Oct 8) said it was recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the United States Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.
2019
Sanofi recalls Zantac in the United States and Canada
Recall announced
In October 2019, Sanofi announced a voluntary recall of Zantac from stores in the United States and Canada. The recall was announced while the company and regulators investigated NDMA detected in the drug. The source report describes the recall as covering the heartburn medication in both markets and links it to the investigation into the detected NDMA.
Sanofi said it would voluntarily recall Zantac from stores in the United States and Canada while the company and regulators investigate NDMA detected in the drug.
Company response
Recall — Sanofi
Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada
Source excerpt
Sanofi said Friday it will recall the widely-used heartburn drug Zantac from stores in the United States and Canada as the drugmaker and Food and Drug Administration investigate a probable carcinogen detected in the drug.
The FDA last month said it discovered a probable carcinogen called NDMA, or nitrosodimethylamine, in the drug Zantac and its generic versions.
2019
CVS suspends sales of Zantac and ranitidine products
Corrective action
CVS Pharmacy said it suspended sales of Zantac-brand and CVS Health-brand ranitidine products until further notice. The suspension followed an FDA alert that ranitidine products may contain a possible human carcinogen. According to the source, the products had not been recalled, and the FDA was not recommending that patients stop taking them.
Source excerpt
CVS Pharmacy announced Saturday that it has suspended the sale of all Zantac brand and CVS Health-brand ranitidine products until further notice
The announcement comes in response to an alert from the FDA that ranitidine products may contain a possible human carcinogen and cause cancer.
While Zantac and ranitidine products have not been recalled, and the FDA is not recommending patients stop taking these products, customers can still return the products to CVS for a refund.