Skip to Main Content

A federal court judge dismissed all claims against dozens of generic manufacturers and retailers in sprawling litigation over allegations that the Zantac heartburn pill may contain a carcinogen, although brand-name drug makers will continue to face more than 1,400 lawsuits over the issue.

The ruling is the latest chapter in an ongoing saga over the safety of the widely used heartburn medicine, which is also known as ranitidine. The pills were recalled by numerous manufacturers in 2019 after the Food and Drug Administration found some contained higher than acceptable levels of NDMA,  an organic chemical that is part of a carcinogenic group of compounds called N-nitrosamines. The agency acted after an online pharmacy discovered the impurity by testing batches and urged the FDA to act.


Studies have shown that these compounds increase the risk of cancer in humans and animals. NDMA is an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions. The World Health Organization and the U.S. Environmental Protection agency consider the impurity to be a possible carcinogen. FDA testing found that NDMA levels increased under normal storage conditions, and increase significantly in samples stored at higher temperatures.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


Create a display name to comment

This name will appear with your comment

There was an error saving your display name. Please check and try again.