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Litigation Update: FDA Orders for an Immediate Removal of Zantac from the Market

Litigation Update: FDA Orders for an Immediate Removal of Zantac from the Market

On April 1st, the FDA announced a global halt of the heartburn medication ranitidine, sold under the brand name of Zantac. This follows an initial warning back in September 2019, when low levels of a toxic compound and probable human carcinogen, NDMA (N-nitrosodimethylamine), were found in the medication.

The decision by the FDA to remove all ranitidine medications from shelves and stop its production resulted from recent studies that showed that some impurities in the products are altered if the medications are stored above room temperature.  Given that it is hard to establish how and for how long the products have been stored, the FDA opted for a full recall.

Patients who are currently on the medication were advised to stop taking it and replace it with other options that do not have the NDMA compound and to consult with their doctors if they are on prescription ranitidine, Zantac. Additionally, patients should not bring back their current Zantac medicines to the store given the risks associated with the coronavirus but should follow the FDA’s safe disposal instructions.

Both Pfizer and Sanofi face litigation arising from claims that Zantac allegedly causes cancer.

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