In early September 2019, the news broke that tests had found “extremely high levels” of the cancer-causing chemical NDMA1 in Zantac and other ranitidine2 products. A few days later, the Food and Drug Administration (FDA) announced that its own “preliminary” tests had also found unsafe (though lower) levels of NDMA in some batches of Zantac and other ranitidine medicines. A series of voluntary recalls began soon thereafter.
Health Canada also began assessing the NDMA levels in ranitidine products. It asked manufacturers to stop distributing Zantac and other ranitidine products in Canada until their NDMA levels were known to be safe, and it announced recalls for many Canadian ranitidine products.
In late September 2019, the makers of Zantac and generic ranitidine products began recalling many batches of their products due to potential NDMA contamination, and many stores pulled unrecalled products from their shelves.
During its investigation, the FDA announced it had found levels of NDMA in some products above the 96 nanogram daily limit the FDA considers “reasonably safe for human ingestion based on lifetime exposure.” The FDA advises companies to recall ranitidine products with higher NDMA levels and has also emphasized that, whatever the level of additional risk, the “presence [of NDMA and other nitrosamine contaminants] in drug products is not acceptable.”