FDA Requests Withdrawal of All Ranitidine Products

April 02, 2020

On April 1, 2020, the U.S. Food and Drug Administration (FDA) asked manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

FDA Requests Withdrawal of All Ranitidine Products

The action is the latest step in an ongoing investigation of a contaminant known as N-nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac®). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA determined that the impurity in some ranitidine products increases over time and, when stored at higher-than-room temperatures, may result in consumer exposure to unacceptable levels of the impurity. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.


Healthcare professionals and patients should report adverse events or side effects related to the use of the products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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