The FDA requested the market withdrawal of all remaining prescription and over-the-counter Zantac® and generic ranitidine heartburn medications. These products will no longer be available in the U.S.
The FDA determined that NDMA in some ranitidine products increases over time, or when stored at higher than room-temperatures.
The agency is asking consumers to stop taking over-the-counter Zantac or ranitidine, or talk to a health care professional about switching prescriptions.
There are several other heartburn medications available, including Pepcid, Tagamet, Nexium, Prevacid, and Prilosec.
Unfortunately, the public was not warned about high levels of NDMA until September 2019, when an independent pharmacy, Valisure, warned that some 150-mg pills contained significantly higher levels of NDMA than the FDA’s acceptable daily intake level.
More than a dozen recalls have already been issued for Zantac and ranitidine due to high levels of a carcinogenic impurity called NDMA. Lawsuits have also been filed by a growing number of people who were diagnosed with cancer after taking Zantac or ranitidine.
Due to the COVID-19 pandemic, the FDA is asking consumers not to take medicines to a drug take-back location. Instead, follow disposal instructions to safely throw it in the trash.