FDA requests recall of all ranitidine products on US market

The US Food and Drug Administration (FDA) has announced its request that all manufacturers withdraw prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

According to the FDA, this is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, a probable human carcinogen. The agency has determined that the impurity in some ranitidine products increases over time, especially when stored at higher than room temperatures, and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US.

“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 did not observe unacceptable levels of NDMA in many of the samples that we tested. However, since we do not 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 Dr Janet Woodcock, 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.”

With the new announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The agency is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and buy no more; for those who wish to continue treating their condition, they should consider using other approved OTC products.