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FDA Recalls All Ranitidine (Zantac) Products Due to Cancer Risk

On April 1, 2020 the Food and Drug Administration (FDA) announced that it was pulling all ranitidine off the shelves due to a possible link to cancer. This recall includes all prescription and over the counter ranitidine (best known by the brand name Zantac).

In September of last year, the FDA put out a warning that an independent laboratory had found Nitrosodimethylamine (NDMA), a probable human carcinogen in ranitidine.( Harvard epidemiology professor Joshua Gagne  describes NMDA as “an environmental contaminant that can be produced by industrial processes like water treatment.”( There is currently limited data on the relationship of NMDA to human cancer; but there is some evidence that it can cause cancer in animals.

At the time of the September warning, the FDA said patients could continue to take the medication, and would not face any health risk from low levels of NDMA. The FDA did not have “enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines and continued its investigation.”

In subsequent testing, the FDA determined that levels of NDMA “in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.”( “While low levels of NDMA are not harmful to humans, sustained higher levels may increase the risk of cancer.”

What is Ranitidine?

According to the FDA, “ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach.” It is used for health issues like heartburn, sour stomach, and acid indigestion.

There are over the counter (OTC) ranitidine drugs (Zantac, for example), and there is also prescription ranitidine for “treatment and prevention of ulcers and treatment of gastroesophageal reflux disease.”

Does Zantac Cause Cancer?

Joshua Gagne says there is no data at this time that links ranitidine to cancer in humans. There is only data that shows that some ranitidine tested has contained NDMA.

When ranitidine is exposed to high temperatures, it can break down to form NDMA, which is a possible carcinogen. “But not all samples tested by the FDA were found to have an unacceptable level of the potential carcinogen.” More long-term studies are needed to find out if long-term use of ranitidine causes cancer in humans.

What should I do if I currently take ranitidine?

Per the FDA, consumers taking OTC ranitidine should immediately stop taking it, dispose of the medicine properly, and not buy anymore. If you wish to continue treatment, consider using other OTC products.

Patients taking prescription ranitidine need to talk to their doctor before stopping the medicine. There are other drugs approved for the same or similar uses that to date have not been found to contain NDMA. Some examples are famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

“The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:


  • Download and complete the form, then submit it via fax to 1-800-332-0178.


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