The FDA has issued a national recall of all Zantac drugs due to a carcinogenic ingredient known to cause cancer in humans.

FDA Recalls Zantac Drugs

Due to mounting consumer complaints and national lawsuits filed with Zantac cancer attorneys, the Federal Food and Drug Administration (FDA) has issued a national recall of Zantac, a popular drug used to treat heartburn and acid reflux problems in adults and some children with active intestinal ulcers. Alarming testing data shows a possible link to Zantac and certain cancers of the stomach, liver, bladder, pancreas, and colon.

The FDA is concerned about alarming test results that link ranitidine products (known by the brand name Zantac) to certain cancers in humans. Testing shows unacceptable levels of NDMA, a probable carcinogen (cancer-causing chemical), found in some ranitidine products. The levels of cancer-causing chemicals in Zantac have been found to be between 3,000 and 26,000 times higher than the levels determined to be safe by the FDA.

Ranitidine is a drug that’s available in a prescription version and an over-the-counter version. Prescription ranitidine comes as an oral tablet, oral capsule, oral syrup, and an injectable solution. Over-the-counter Zantac comes in an oral tablet and a liquid.

Zantac is usually prescribed for short periods of time, but some people with stomach ulcers and gastrointestinal disorders take it for longer periods. FDA testing shows that NDMA impurity levels increase significantly when ranitidine products are stored over time or at higher temperatures, including high temperatures products may be exposed to during distribution by retailers and handling by consumers. Testing also shows that ranitidine products with older manufactured dates show much higher levels of NDMA.

In 2020, the FDA requested all manufacturers of Zantac to recall both prescription and over-the-counter drugs from the market immediately. Major retailers and pharmacies including Kroger, Target, Walmart, CVS, Rite Aid, and Walgreens have pulled prescription and over-the-counter formulas of Zantac from their shelves. In addition, Sanofi, Zantac’s brand-name manufacturer, as well as 14 generic manufacturers have recalled the drug in the United States.

The FDA is advising consumers who take over-the-counter Zantac to stop taking any medications they currently have, and seek other drugs approved for the same or similar uses without possible cancer risks. Patients taking prescription Zantac or other ranitidine products are advised to consult with their doctor for a safe drug replacement without personal injury risks from NDMA impurities found in Zantac.

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