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# Ranitidine Products May Return to Market: FDA
- URL: https://www.fdaweb.com/ranitidine-products-may-return-to-market-fda/
- Published: 2021-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:12:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150057

FDA says new analytical methods for detecting the carcinogen NDMA (N-nitrosodimethylamine) developed by CDER scientists have shown that actual levels of NDMA in ranitidine drug products were much lower than previously reported. In the “What is New in Regulatory Science” online summer [issue](http://www.fda.gov/media/151904/download?ref=fdaweb.com), CDER says that to further address the cancer risk of ranitidine, a popular drug used to treat peptic ulcer and gastroenterological reflux disease that has been withdrawn from the market, the Center conducted a randomized clinical trial that concluded that ranitidine does not increase NDMA under physiological conditions.

“Based in part on this research, FDA may consider allowing ranitidine-containing products back on the market if they are proven to be stable, with low acceptable amounts of NDMA that do not increase during storage,” the newsletter says.

Other articles in the newsletter cover Covid-19 related updates, spotlight on CDER science, regulatory science impact stories, recent CDER staff science publications, upcoming events, and career opportunities.