US FDA orders the disposal of Ranitidine

After months of study, the FDA has concluded that the ranitidine drug contains unacceptable levels of carcinogenic impurities and called for its disposal.

About the Issue

The US Food and Drug Administration had tested the drug ranitidine over several months for presence of impurities. It discovered the presence of a carcinogenic substance called NDMA. It found that the level of NDMA in the drug increased over time. Hence drugs that have been in storage for longer contain more impurities. The FDA has recommended the use of alternatives drugs and disposal of the ranitidine drugs rather than recall.


Ranitidine is a prescription drug but is also used as an OTC (over the counter) drug. Sold under the trade name of Zantac, it is used in treatment of acidity. It reduces the volume of acid produced in the stomach and helps relieve heartburn caused by sour stomach and acid indigestion. It is also used in treatment of ulcers, gastroesophageal reflux disease, etc.


The FDA found NDMA contamination in the drugs. NDMA or N-Nitrosodimethylamine is a carcinogenic substance. Though NDMA is common in food and water, low levels of the compound do not increase the risk of cancer. However, higher levels of NDMA are known to be not only carcinogenic, but also hepatotoxic (affects the liver). Several drugs have been recalled in the past due to NDMA contamination- such as metformin (an anti-diabetic drug), valsartan (for treating high BP), etc.



Latest E-Books