FDA Asks Manufacturers to Remove Zantac (Ranitidine) Products from the Market

On April 1, 2020, The U.S. Food and Drug Administration announced its request that manufacturers of popular over-the-counter heartburn drugs containing ranitidine remove those products from the market. This includes the brand name drug Zantac and its generic versions.

The request came after the agency determined that impurities in some ranitidine products increases over time when stored above room temperature, which may expose consumers to unacceptable levels of NDMA, a probable human carcinogen.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

NDMA, which may cause several types of cancer, was detected at low levels in samples of Zantac in the summer of 2019. While the levels that were discovered may not be expected to lead to an increased risk of cancer, sustained higher levels of the substance could present a serious health risk for consumers taking Zantac.

While the FDA’s determination that the drug should be removed from the market until its safety can be assured is a non-enforceable request, it sends a powerful message to consumers. The FDA is advising consumers taking over-the-counter ranitidine drugs like Zantac to stop taking any tablets or liquid they currently have, and consider using other approved alternatives.