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.
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, more product recalls and injury lawsuits may follow. 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.