Zantac, Zantac OTC and Ranitidine Recall Issued Due to NDMA Contamination
Following months of concerns about whether side effects of ranitidine in Zantac increase the risk of cancer, the U.S. Food and Drug Administration (FDA) announced today that all ranitidine-based drugs should be removed from the market, including name-brand Zantac, over-the-counter and all generic equivalents.
Contact Our Lawyers To Review a Zantac/Ranitidine Recall Case
Our lawyers have been investigating Zantac recall lawsuits since information about the risk of NDMA contamination first emerged in September 2019, pursuing financial compensation for former users of the medications who have been diagnosed with:
- Prostate Cancer
- Breast Cancer
- Stomach Cancer
- Colorectal Cancer
- Esophageal Cancer
- Pancreatic Cancer
- Bladder Cancer
- Liver Cancer
- Kidney Cancer
- Other Digestive Tract Cancers
FDA Warning Issued April 1, 2020
The FDA issued an updated Zantac/ranitidine recall notice today, 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 is unable to determine how long different versions of Zantac have been stored, all manufacturers are being 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.
With these new recommendations, the agency has finally 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).”
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for individuals nationwide who suspect that they may have already developed cancer from Zantac exposure.
It appears the drug makers knew for decades that ranitidine contained NDMA, a chemical that is known to cause cancer in humans. However, rather than investigating the risk and warning about the side effect of ranitidine, Zantac and generic equivalents continued to be sold as a safe and effective treatments.
If you, a friend or family member have been diagnosed with cancer after at least three months of Zantac use, request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, meaning there are no out-of-pocket expenses and our attorneys receive no fees unless a settlement or court judgment is reached.