The FDA announced on September 13, 2019, that low levels of a probable human carcinogen called N-nitrosodimethlylamine (NDMA), were found in Zantac (ranitidine). As a result, major drugstores such as Walgreens and CVS have taken all generic versions of ranitidine and Zantac off their shelves until further notice from the FDA. Drug manufacturers, Sandoz (a division of Novartis) and Apotex have also decided to take action and are recalling all of their generic ranitidine drugs that are sold in the United States. Just months later, the FDA officially announced on April 1, 2020 that all ranitidine products, including Zantac, were to be taken off the market. This removal was determined appropriate after new laboratory tests on various storage scenarios for ranitidine products found dangerous NDMA-related results.
The potentially cancer-causing impurity NDMA has also been found in widely used blood pressure medications such as Valsartan. This led to multiple recalls of the drugs as well as hundreds of drug injury lawsuits. Now that the FDA is finding similar evidence of the same impurities in ranitidine drugs, ranitidine product recalls and injury lawsuits have followed. The FDA is working with multiple international agencies to review the medications and to determine if the impurities pose a health risk to users. The agency is also asking ranitidine manufacturers to perform tests on their individual products and to send samples to the FDA for additional examinations. The most recent data from the FDA and 3rd party labs have brought to attention the effect of time and storage on the levels of NDMA in ranitidine medications. It was found that NDMA levels will increase in these drugs over time, at regular temperatures, and at high temperatures.