To assist you in the care of your patients, we want to alert you to the market withdrawal of , opens new window on April 1, 2020.1 We recommend you review your medical records and contact all patients for whom you have prescribed ranitidine to warn them of the recall. You also may have patients who have taken over-the-counter (OTC) ranitidine medications; please advise those patients of the recall. We have listed alternative options below.
The U.S. Food and Drug Administration (FDA) announced that it is requesting manufacturers to withdraw all prescription and OTC ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac®).
NDMA is a probable human carcinogen. Low levels of NDMA are commonly ingested in the diet. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans.
NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling. Also, the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. The FDA determined that some ranitidine products may result in consumer exposure to unacceptable levels of this impurity.
Monitor the , opens new window for the most up-to-date ranitidine recall information.