Zantac, Zantac OTC, and Ranitidine Recalled Over NDMA Cancer Risk

By Austin Kirk
Posted April 1, 2020

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Following concerns about whether side effects of ranitidine in Zantac increase the risk of cancer, the U.S. Food and Drug Administration (FDA) announced that all ranitidine-based drugs should be removed from the market, including name-brand Zantac, over-the-counter and all generic equivalents.

Our lawyers began investigating Zantac recall lawsuits in September 2019, after information emerged about the risk of NDMA contamination in ranitidine-based medications. Legal claims were pursued on behalf of former users who were diagnosed with:

• Bladder Cancer
• Esophageal Cancer
• Liver Cancer
• Pancreatic Cancer
• Stomach Cancer

Our firm is no longer accepting new Zantac cases. The information on this page is provided for informational and historical reference only.

FDA Zantac Warning

The FDA issued an updated Zantac/ranitidine recall notice on April 1, 2020, acknowledging that the carcinogenic chemical byproduct N-Nitrosodimethylamine (NDMA) may contaminate the drugs over time, especially when stored at higher than room temperatures.

Since the regulatory agency was unable to determine how long different versions of Zantac have been stored, all manufacturers were asked to remove ranitidine drugs from the market.

Public information about the link between Zantac and cancer-causing chemicals was not available until September 2019, when the independent pharmacy Valisure filed a Citizen’s Petition for a ranitidine recall (PDF) with the FDA, indicating that independent testing detected high levels of NDMA across all versions of Zantac manufactured by multiple different drug makers.

Although the FDA has previously established that the permissible human intake of NDMA is only 96 ng per day, testing by Valisure found some pills contained up to 3 million ng.

Over the past few months, certain drug makers have issued Zantac/ranitidine recalls, after specific lots of the drug were confirmed to contain levels of NDMA that pose a specific health risk. However, not all Zantac was recalled until this new statement issued by the FDA.

At the time, the agency acknowledged that the piece-meal method of recalling ranitidine drugs and testing individual versions of the medication is no longer feasible, since NDMA levels continue to increase over time during storage.

“With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).”

Zantac/Ranitidine Lawsuits

The product liability lawyers at Saiontz & Kirk began reviewing Zantac cancer claims after it was discovered that the heartburn drug may expose users to the cancer-causing chemical N-Nitrosodimethylamine (NDMA).

Allegations raised in the litigation suggested that drug manufacturers knew for decades that ranitidine could contain or form NDMA, a chemical classified as a probable human carcinogen. Despite this, Zantac and its generic equivalents continued to be marketed and sold without warnings about the potential cancer risks.

2022 Update: Following several years of litigation and a detailed review of the available medical literature, the scope of claims was narrowed to include only those cancers that could be scientifically supported at trial.

All claims were handled on a contingency fee basis, with no out-of-pocket expenses required. Legal fees were only collected if a settlement or court award was obtained.