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Zantac High Levels of NDMA but No Recall Class Action

Box of Zantac

This complaint concerns a drug brand-named Zantac, and names as defendants maker Sanofi US, LLC, distributor Chattem, Inc., and sellers CVS Health Co. (formerly CVS Caremark) and Dollar Tree Stores, Inc. The complaint alleges that the drug contains “dangerously high levels or N-nitrosodimethylamine (NDMA).

The class for this action is all persons in the US who bought Zantac. The complaint also proposes a New York Subclass.

Zantac is an over-the-counter drug that lowers the amount of acid made by the stomach. It’s sold as a treatment for heartburn that comes from indigestion or sour stomach. Unfortunately, the complaint alleges that Sanofi’s manufacturing process has somehow introduced NDMA into the drug. 

The complaint quotes the Environmental Protection Agency as saying that NDMA is part of “a family of potent carcinogens.” The substance is currently made in the US only for research purposes, but it used to be used in making liquid rocket fuel. 

The complaint says, “NDMA is listed as a ‘priority toxic pollutant’ in federal regulations. … Exposure to NDMA can cause liver damage and cancer in humans. NDMA is classified as a probable human carcinogen and animal studies have shown that ‘exposure to NDMA has caused tumors primarily of the liver, respiratory tract, kidney and blood vessels.’”

In September 2019, the Food and Drug Administration (FDA) announced that it had found NDMA in ranitidine medicines, including Zantac. It has since then said its own testing “has found unacceptable levels of NDMA in samples of ranitidine.”

Although other makers have issued recalls or stopped the sale of ranitidine medications, Sanofi has yet to issue a recall of Zantac. According to the complaint, Sanofi continues to market Zantac as if it is safe, despite the findings of NDMA in ranitidine. 

Health authorities in Ireland have issued a recall of ranitidine, saying that “a nitrosamine impurity has been identified in ranitidine active substance batches manufactured at a manufacturing site in India.”

The complaint says that the FDA has established a “permissible daily intake limit” for NDMA of 96 nanograms, but that the levels of NDMA found in Zantac is between 2.5 and 3.3 million nanograms per tablet. It also quotes a Stanford University study that says that people who took Zantac had levels of NDMA in their urine “more than 400 times greater than what the FDA considers acceptable.”

The complaint alleges breaches of warranties, fraudulent concealment, and violations of laws prohibiting deceptive acts or practices and false advertising, among other things.  

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