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On April 01, 2020, the U.S. Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitroso dimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac.

FDA Requests Removal of All Ranitidine Products

The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC
use in the U.S

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FDA continues to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine. Both medicines are H2 blockers which decrease the amount of acid in the stomach. FDA has identified NDMA in ranitidine and nizatidine active pharmaceutical ingredient (API) and finished drugs.  
 
FDA is posting its laboratory results in the table below showing NDMA levels in all ranitidine and nizatidine samples it tested, including API and finished drug which included tablets and syrup. NDMA was present in all samples tested. Testing of ranitidine for injection is still ongoing.
 
 For reference, consuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine. Although many manufacturers have already recalled ranitidine voluntarily, FDA will recommend recalls to manufacturers with NDMA levels above the acceptable daily intake limit.
 

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