UPDATE: FDA Pulls All Remaining Zantac Off Store Shelves
In April 2020, the FDA pulled all remaining Zantac and ranitidine off store shelves in the U.S. due to the risk of cancer. The agency determined that levels of a cancer-causing chemical impurity (NDMA) can increase in the pills over time, or when the pills are stored above room-temperature. This means all over-the-counter and prescription-strength Zantac and ranitidine will no longer be sold in the U.S.
Zantac® Recall
There are over a dozen recalls for over-the-counter Zantac, prescription-strength Zantac, and generic ranitidine due to NDMA contamination.
On October 18, 2019, Sanofi recalled over-the-counter Zantac® in the U.S. and Canada after tests confirmed NDMA contamination.
Earlier in October 2019, GlaxoSmithKline recalled prescription-strength Zantac® pills (150-mg and 300-mg), injections, and a syrup.
Walmart, Rite Aid, CVS, Walgreens Stop Selling Zantac
Generic Zantac Recalls
Has generic Zantac been recalled? Walmart, CVS, Rite Aid, Target, Walgreens, and other stores have stopped selling ranitidine and other products that contain ranitidine due to the risk of cancer. Below is a list of recent recalls:
- 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 issued a warning after Zantac® heartburn medications and generics tested positive for NDMA (N-nitrosodimethylamine).
What is the Problem?
The FDA has been testing medications for NDMA since 2018, when drug-makers in India and China were forced to issue numerous recalls for several blood-pressure drugs that were contaminated by NDMA.
Cancers Linked to NDMA
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Esophageal cancer
- Testicular cancer
- Ovarian cancer
- Bladder cancer
Tests Find High Levels of NDMA in Medications
Zantac had NDMA levels as high as 3,000 micrograms, according to Bloomberg. In comparison, the recalled blood-pressure drugs only had NDMA levels up to 17 micrograms.
What’s the Limit?
The FDA set a limit of less than 1 microgram of NDMA in blood-pressure medications after recalls were issued for valsartan, irbesartan, and losartan blood pressure drugs in 2018. The FDA also now requires drug-makers to test their pills for NDMA contamination.
What is NDMA?
N-Nitrosodimethylamine (NDMA) is a highly toxic chemical impurity that is known to cause cancer in animals, and likely in people as well. NDMA is created in the industrial processes to make Zantac, specifically when drug-makers reuse solvents or other materials.
Does NDMA Cause Cancer?
NDMA classified as a “probable human carcinogen” by the World Health Organization’s cancer research experts. Because it is so toxic to animals, no experimental studies have been conducted in people.
Is My Heartburn Pill Safe?
NDMA is extremely toxic to the liver. People who have been poisoned by NDMA died of liver failure and severe internal bleeding. Furthermore, NDMA likely causes cancer in people.
Zantac Lawsuits for Cancer
People who were diagnosed with cancer may be eligible to file a Zantac lawsuit or join a class action. The litigation may resemble lawsuits involving Valsartan, a blood pressure drug that was also contaminated with NDMA. Those lawsuits have been centralized in a Multi-District Litigation (MDL), similar to a class action.
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