FDA approves reformulated antacid 5 years after it was pulled from shelves

WASHINGTON — The U.S. Food and Drug Administration has approved a reformulated version of ranitidine, which was sold widely under the brand name Zantac, allowing the acid-reducing drug to return to the market nearly five years after it was withdrawn nationwide over concerns an impurity could cause cancer.

The FDA said the new formulation addresses the risk of N-nitrosodimethylamine, or NDMA, an impurity that can form during storage and is classified as a probable human carcinogen. Ranitidine products, including Zantac, were pulled from shelves in April 2020 after regulators determined the impurity could increase to unsafe levels over time, particularly when stored at higher temperatures.

The newly approved tablets underwent “extensive safety testing and manufacturing improvements” to