UPDATE: FDA Pulls All Zantac Off Store Shelves
In April 2020, the FDA ordered manufacturers to pull all Zantac and generic ranitidine off the market in the U.S. due to the risk of cancer, including all over-the-counter and prescription-strength products. The FDA warned that NDMA, a cancer-causing chemical impurity, can increase in the pills over time, or when the pills are stored above room-temperature.
Has Zantac Been Recalled?
Yes. There are over a dozen recalls for over-the-counter Zantac®, generic ranitidine, store-brand heartburn medications, prescription-strength Zantac, and other products that contain ranitidine.
FDA Finds NDMA Carcinogen in Zantac
In September 2019, the FDA issued a Safety Warning for people who take Zantac® heartburn pills and generic ranitidine after a cancer-causing impurity called NDMA was detected in some medications.
How Much NDMA is in Zantac?
The recalls were issued after a small online pharmacy called Valisure discovered that some Zantac tablets contained up to 29,000 times the FDA’s daily recommended limit of NDMA.
Bloomberg reported that Zantac tested positive for up to 3,000 micrograms of NDMA, which is significantly higher than the FDA limit of less than 1 microgram of NDMA in medicines.
What is N-nitrosodimethylamine?
N-nitrosodimethylamine (NDMA) is a chemical that is classified as a probable human carcinogen (a substance that could cause cancer). NDMA gets into medicines when it is left over from the manufacturing process as an impurity — specifically when drug-makers reuse certain materials, such as solvents. NDMA was also formerly used in the production of liquid rocket fuel.
NDMA in Blood-Pressure Drugs Leads to Recalls
NDMA contamination in medications is a major problem for drug-makers in India and China, who were recently forced to issue dozens of recalls for blood-pressure drugs that were contaminated by NDMA. These recalled drugs include Diovan, Valsartan, Irbesartan, and more.
Is NDMA in My Food?
NDMA is also commonly found in the environment, including water and foods such as meats, dairy products, and vegetables.
Cancers Linked to NDMA
- Liver cancer
- Kidney cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Ovarian cancer
- Esophageal cancer
- Testicular Cancer
- Bladder cancer