FDA: Remove All Ranitidine Products From Availability

The US Food and Drug Administration has announced that it is requesting that manufacturers withdraw all prescription and over-the-counter ranitidine drugs (Zantac) immediately.

The request is the latest in an ongoing investigation into potential contamination of the drugs with N-Nitrosodimethylamine (NDMA), which could increase over time when the medication is stored at a higher than room temperature.

While low levels of NDMA are commonly found in and ingested with foods and water, sustained high levels of exposure could cause cancer. In 2019, the FDA learned of independent research that found NDMA in ranitidine, but after conducting their own laboratory tests, found only low levels.

Further testing, however, revealed that NDMA levels increase in ranitidine even under normal storage conditions, leading to the withdrawal of the medication from availability.

At this time, FDA testing has not revealed NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

—Michael Potts

Reference:
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. News release. US Food and Drug Administration; April 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market.