Why the FDA Recalled Zantac and All Ranitidine Products

Why the FDA Recalled Zantac and All Ranitidine Products

Due to dangerous ingredients linked to human cancers, the FDA has requested an immediate recall of Zantac drugs, including all prescription and over-the-counter ranitidine products.

Zantac and Ranitidine Products Linked to Cancer

The U.S. Food and Drug Administration (FDA) has issued a recall for Zantac, a well-known heartburn medication taken by millions of Americans. Zantac and ranitidine products (generic forms of Zantac drugs) have been linked to numerous gastrointestinal cancers caused by a known carcinogenic ingredient linked to cancers in humans and some children.

Zantac and ranitidine products can be purchased in both prescription and over-the-counter (OTC) drugs that are commonly used to relieve problems with heartburn and acid reflux. Prescription strengths are usually prescribed to treat and prevent ulcers in the stomach and intestines, while OTC products in lower doses are most often used to treat heartburn, indigestion, and GERD, a gastrointestinal disorder.

After numerous consumer complaints and lawsuits by Zantac cancer attorneys, the FDA is investigating the safety of Zantac and ranitidine products. In 2019, FDA testing revealed concerning levels of an ingredient called N-nitrosodimethylamine (NDMA) in ranitidine. NDMA is considered a probable human carcinogen that has been linked to gastrointestinal cancers of the esophagus, stomach, liver, bladder, pancreas, and colon. NDMA is considered especially dangerous because it breaks down during normal digestive processes into tiny particles that can be absorbed by internal organs. It is also known to break down when stored in high heat or over long periods of time on store shelves or in medicine cabinets.

Although FDA testing has found low levels of NDMA in some Zantac products, higher levels have been found in ranitidine (generic forms of Zantac). The levels of cancer-causing chemicals in some ranitidine drugs are 3,000 times higher than the levels determined to be safe by the FDA. Testing also shows that ranitidine drugs with older manufactured dates show much higher levels of NDMA, confirming FDA concerns about NDMA breakdown during long storage times.

Due to growing concerns about public health and safety, FDA recalls have been issued to manufacturers of all Zantac and ranitidine prescription drugs and OTC products. In response to the recall, major retailers and pharmacies across the country including Target, Walmart, Walgreens, Rite Aid, and CVS have pulled prescription drugs and OTC products off the shelves. Consumers who take prescription and OTC Zantac or ranitidine products are advised to consult with their doctors for a safer replacement drug without cancer risks.