What Happened? | Zantac and NDMA

ALERT: April 1, 2020 Zantac and NDMA – “The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine (Zantac) drugs from the market immediately.”


Since the 1980s, ranitidine (brand name: Zantac) has been associated with NDMA. While Zantac is not contaminated with NDMA, it contains nitrite (N) and dimethylamine (DMA). Combined, they form the carcinogen NDMA.

Unacceptable Levels of Carcinogen in Zantac | Zantac and NDMA


Online pharmacy Valisure notified the Food and Drug Administration (FDA) in June of 2019 that routine testing done in their labs had linked Zantac to a carcinogen (a substance or agent causing cancer) called N-nitrosodimethylamine (NDMA). Following the notification and a petition for recall filed by Valisure, FDA’s own testing found unacceptable levels of NDMA in Zantac.

Zantac and NDMA | What is NDMA? 

“The chemical N-Nitrosodimethylamine, or NDMA, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste. It’s known to cause cancer in animals and is classified as a probable carcinogen in humans—it’s most toxic to the liver. A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days.” (Carcinogens Have Infiltrated the Generic Drug Supply in the U.S., by Anna Edney, Susan Berfield, and Evelyn Yu; Bloomberg Businessweek)

According to the Agency for Toxic Substances and Disease Registry, “NDMA was used to make rocket fuel, but this use was stopped after unusually high levels of this compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant. NDMA is, however, unintentionally formed during various manufacturing processes at many industrial sites and in air, water and soil from reactions involving other chemicals called alkylamines.”


In its report on NDMA, the World Health Organization says “There is conclusive evidence that NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking-water. NDMA has been classified by IARC (International Agency for Research on Cancer) as probably carcinogenic to humans.”

How is NDMA linked to Zantac?

Zantac and NDMA — Since the 80s, ranitidine (brand name: Zantac) has been associated with NDMA. While Zantac is not always contaminated with NDMA, it contains nitrite (N) and dimethylamine (DMA). Combined, they form the carcinogen NDMA in the human stomach.

“Ranitidine, sold under the trade name Zantac®, is […] commonly used to treat gastroesophageal reflux disease and gastric and duodenal ulcers. Previous research has demonstrated that certain pharmaceuticals [like Ranitidine] can form N-nitrosamines [NDMA] via reactions with nitrite at stomach-relevant pH in vitro [i.e. endogenous nitrosation]. N-Nitrosamines are considered likely human carcinogens, and have been implicated in the induction of stomach, esophagus and nasopharynx cancers. Additionally, considerable evidence indicates N-nitrosamines as the etiological agents for bladder cancer associated with schistosomiasis.” (Teng Zeng, William A. Mitch, Carcinogenesis, Volume 37, Issue 6, June 2016, Pages 625–634)

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Peiffer Wolf is committed to making sure that the companies that release harmful drugs or medical devices onto the market are held accountable for their wrongful conduct. If you have been diagnosed with cancer after taking Zantac regularly, please contact the attorneys at Peiffer Wolf by filling out an online contact form or by calling 504-523-2434 for a FREE Consultation.

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