Some generic versions of the heartburn drug Zantac are being recalled in the United States because they may contain low levels of N-nitrosodimethylamine (NDMA), a substance that could cause cancer, according to the U.S. Food and Drug Administration.
As of Sept. 27, two manufacturers had issued recalls of ranitidine in the United States. Better known under the brand name Zantac, prescription ranitidine is approved to treat gastroesophageal reflux disease and treat and prevent stomach and intestinal ulcers while over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach.
One ranitidine recall includes over-the-counter generic versions sold at Walgreens, Walmart and Rite Aid, and the other includes batches of generic prescription capsules. Both companies cited the potential cancer-causing impurity NDMA as the reason.
Not all ranitidine medications sold in the United States are being recalled. Brand name Zantac has not been affected by the recalls.
The recent cancer concerns follow a series of manufacturer recalls that began last year involving tainted valsartan and other angiotensin receptor blockers used to treat high blood pressure. The FDA’s investigation into NDMA-contaminated drugs is ongoing.
“FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking ranitidine,” according to the agency. “Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity.”
Prescription Ranitidine Manufacturer Sandoz Inc. Stops Distribution and Issues Recall
Manufacturer Sandoz Inc. issued a voluntary recall of 14 lots of prescription ranitidine on Sept. 23. In a statement, the company said officials had confirmed that batches of Sandoz Ranitidine Hydrochloride Capsules 150 mg and 300 mg contained unacceptable levels of NDMA.