Removal of Ranitidine from Market

Removal of Ranitidine from Market
Released: 04/15/2020  

The Food and Drug Administration (FDA) recently announced a request for manufacturers to remove all ranitidine from the market, this includes both prescription and over the counter (OTC) formulations. The brand name for ranitidine is Zantac. This request for removal stems from several recalls issued earlier this year due to a possible contaminant, N-Nitrosodimethylamine (NDMA), in many ranitidine products.  The FDA determined that the levels of this impurity may increase over time, especially when stored at higher temperatures, and result in unacceptable levels of NDMA.

The FDA is sending out letters to all manufacturers with the request to remove ranitidine products from the market.  If you are a patient currently taking prescription ranitidine, contact your healthcare professional to discuss other treatment options. Do not stop taking your current medication until speaking with your physician. If someone is taking OTC ranitidine, they should consider stopping the medication and discuss alternatives with a healthcare professional.

For more information, visit the FDA’s website at:  https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market