UPDATE: FDA Pulls All Remaining Zantac Off the Market Due to Cancer Risk
In April 2020, the FDA ordered manufacturers to pull all remaining OTC and prescription Zantac (ranitidine) heartburn pills off the market due to the risk of cancer from a chemical impurity called NDMA. The FDA warned that NDMA levels can increase in the pills over time, or if the pills are stored above room-temperature. Zantac will no longer be available in the U.S. and patients should switch to another heartburn medication.
Walmart, Walgreens, Rite Aid, CVS Stop Selling Zantac
Was Zantac recalled? Yes. On October 18, 2019, Sanofi voluntarily recalled over-the-counter Zantac® in the U.S. and Canada due to a risk of NDMA contamination.
Earlier in October 2019, GlaxoSmithKline recalled prescription-strength Zantac® pills (150-mg and 300-mg), injections, and a syrup.
Generic Zantac (Ranitidine) Recalls
Walmart, CVS, Rite Aid, Target, Walgreens and other stores have suspended sales of generic Zantac (ranitidine) and medicines that contain ranitidine while the risk of cancer is under investigation.
There are several recalls for ranitidine and products that contain ranitidine, including:
- RECALL (1/07/2020): Appco Pharma LLC / ANI Pharmaceuticals
- RECALL (1/06/2020): Denton Pharma, Inc. dba Northwind Pharmaceuticals
- RECALL (12/20/2019): Glenmark Pharmaceuticals Inc.
- RECALL (11/8/2019): American Health Packaging
- RECALL (11/8/2019): Amneal Pharmaceuticals LLC
- RECALL (11/8/2019): Aurobindo Pharma USA, Inc.
- RECALL (10/28/2019): Lannett
- RECALL (10/25/2019): Novitium Pharma
- RECALL (10/23/2019): Dr. Reddy’s
- RECALL (10/23/2019): Perrigo Company
- RECALL (9/23/2019): Sandoz Inc.
- RECALL (9/25/2019): Apotex Corp.
Zantac Tests Positive for NDMA Carcinogen
In September 2019, the FDA warned consumers and doctors that some Zantac® heartburn pills and generics were contaminated with a cancer-causing impurity called NDMA (N-nitrosodimethylamine).
List of Cancers Linked to NDMA
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Ovarian cancer
- Testicular cancer
- Bladder cancer
How Much NDMA is in Zantac?
The online pharmacy Valisure discovered that some Zantac tablets contain up to 29,000 times the FDA’s daily recommended limit of NDMA. Valisure tests detected NDMA levels as high as 3,000 micrograms in Zantac and generics. To put this level in perspective, the recalled blood-pressure drugs only had NDMA levels up to 17 micrograms, according to Bloomberg.
NDMA in Blood-Pressure Drug Recalls
After recalls were issued for the blood-pressure drugs, the FDA set a limit of less than 1 microgram of NDMA for blood pressure drugs required all companies that make the drugs to test for NDMA.
The FDA has been investigating NDMA in blood pressure and heart failure medicines since 2018. Manufacturers in India and China have issued numerous recalls for valsartan, losartan, and irbesartan.
What is NDMA?
N-Nitrosodimethylamine (NDMA) is a highly toxic chemical impurity that is left over from the industrial processes used to make Zantac. NDMA is created when drug-makers reuse certain materials, such as solvents. NDMA is particularly harmful to the liver. People who were poisoned by NDMA have died of severe liver damage and internal bleeding.
Does NDMA Cause Cancer?
NDMA is known to cause cancer in animals and it is used by researchers for this purpose. Mice, rats, and other animals will develop liver cancer, lung cancer, or non-cancerous liver damage if they are fed NDMA for more than a few weeks. In pregnant animals, NDMA causes stillbirth and birth defects.
Because it is so toxic, there are no experimental studies in people. NDMA is classified as a “probable human carcinogen” by the World Health Organization’s International Agency for Research on Cancer (IARC).
Is NDMA in My Food?
NDMA is also a common environmental contaminant that is found in water and foods such as meats, dairy products, and vegetables.
Zantac Cancer Lawsuits Centralized in New Jersey MDL
A growing number of lawsuits have been filed by people who were diagnosed with cancer after using Zantac. In fact, Zantac lawsuits could be very similar to lawsuits involving Valsartan, a blood pressure drug that was recalled due to NDMA contamination. The lawsuits are consolidated into a Multi-District Litigation (MDL) in New Jersey, which is very similar to a class action lawsuit.