Update: FDA Requests Immediate Removal of All Ranitidine Products (Zantac and Generic) from the Market

On April 1, 2020, the U.S. Food and Drug Administration (FDA) announced an immediate withdrawal of all products containing ranitidine.  This marks a significant milestone in the agency’s ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac.  NDMA is a probable human carcinogen, which means it is a substance that can cause cancer, most often at higher levels of exposure.

box of the now recalled Zantac

On April 1, 2020, the U.S. Food and Drug Administration (FDA) announced an immediate withdrawal of all products containing Ranitidine.

Similar types of NDMA exposure have been linked to various primary cancers, including:

  • Liver
  • Lung
  • Esophageal
  • Pancreatic
  • Liver
  • Kidney
  • Bladder
  • Colorectal
  • Stomach

After extensive testing and evaluation from third-party laboratories, the FDA has confirmed that NDMA levels increase in ranitidine under normal storage conditions and even more significantly when stored at higher temperatures.  Notably, the FDA states that these medications could be exposed to higher temperatures during the distribution and handling process before consumers even purchase them.

With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking over-the-counter (OTC) ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more.  For those who wish to continue treating their condition, they should consider using other approved OTC products.  Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

The FDA’s emergent action comes on the heels of a 2019 voluntary recall by Sanofi, the drugmaker that produces Zantac.

If you or someone you know has been diagnosed with cancer and you took Zantac OTC or another form of ranitidine for an extended period of time, you may be eligible to recover damages. Contact  Allen & Allen today, for a free case evaluation.