Zantac®, or Ranitidine, is an over–the–counter (OTC) and prescription medicine used to treat acid reflux disease. Zantac® is an H2 (histamine–2) blocker, which decreases the amount of acid created by the stomach. Over–the–counter Zantac® is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Zantac® is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Zantac® and other ranitidine medications are being recalled by the U.S. Food and Drug Administration (FDA).
On April 1, 2020, the U.S. Food and Drug Administration announced it was requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This was 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®). The agency 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.