UNITED STATES—Both prescription and over the counter ranitidine drugs, known as Zantac have been recalled by the U.S. Food and Drug Administration as of Wednesday, April 1.
The FDA reported an ongoing investigation that determined there are levels of a contaminant in the medications that increase over time and can be a risk to public health. Specifically, when the medication is stored at higher than normal temperatures.
The contaminant, N-nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since summer 2019. FDA officials state that because it is too difficult to determine how or for how long the product is being stored, they decided to recall the product until it can be determined safe to place back on the market. The FDA sent out letters to all manufacturers of ranitidine and consumers are being asked to stop taking the medication and to dispose of it.
Due to the current coronavirus pandemic, the FDA asked consumers to safely dispose the medication as explained in the medication guide or insert, rather than returning it to a “drug take-back location.”
Safe products to use instead, as recommended by the FDA include famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec, and if none of these options are available, consumers are informed to speak to their doctor to determine the proper medication.