Valisure’s discovery of NDMA in certain batches of Zantac prompted the FDA to launch an investigation. The FDA continued to test batches of generic ranitidine products and Zantac medication for the presence of NDMA to determine whether or not the drugs contained dangerously high levels. In April 2020, the FDA requested the removal of all ranitidine products from the American market, including Zantac.
The FDA issued this decision for several reasons. The FDA explains that, while low levels of NDMA will not affect cancer risk, a Zantac patient may ingest unacceptable levels of NDMA. The FDA’s investigation determined that some ranitidine products contain dangerous levels of NDMA contamination. This impurity may worsen the longer a product is stored and may increase when a product is exposed to higher than room temperatures. In some cases, NDMA levels increased even when researchers stored the drug properly.
Due to the uncertainty of the supply chain and the volatility of the NDMA impurity, the FDA recommends that all Zantac patients immediately stop taking the drug and dispose of the medication safely.