Did the FDA Recall Zantac?

The United States Food and Drug Administration decided to recall Zantac products in all U.S. markets in April 2020. The recall comes after test results show the tendency of Zantac and other products made with ranitidine to produce NDMA when stored for an extended time. The FDA identifies NDMA as a probable carcinogen for humans. The recall includes both prescription and non-prescription Zantac products. 

Zantac has been available to Americans for more than three decades. Millions of Americans have used this medicine during this time. Individuals still in possession of a prescription drug removed from the market should speak to a physician about taking the remainder of the medication. 

What is Zantac

Zantac is commonly sold over the counter as an aid to consumers suffering heartburn and indigestion caused by high levels of stomach acids. Zantac is also prescribed by doctors to treat patients for conditions like:

  • Gastric ulcers
  • Duodenal ulcers
  • Gastroesophageal reflux disease
  • Overproduction of stomach acid
  • Problems with esophagus

NDMA Explained

The carcinogen NDMA is an organic compound that forms during industrial processes. NDMA forms naturally due to the molecular structure possessed by Zantac’s active ingredient, ranitidine. This molecular structure includes two elements that are necessary for NDMA formation. 

Exposure to the NDMA present in Zantac has been linked to many cancers of the digestive system. These cancers include:

  • Stomach cancer
  • Pancreatic cancer
  • Prostate cancer
  • Intestinal cancer
  • Non-Hodgkin’s Lymphoma
  • Esophageal cancer

First Signs of Trouble

The FDA was made aware of the potential for NDMA associated with Zantac in September of 2019 when an online pharmacy informed the administration they found the cancer-causing agent in Zantac samples. Major retailers responded to the revelation by pulling the medicine from their shelves. The voluntary recall efforts continued with Zantac’s manufacturer, Sanofi, along with 14 generic ranitidine manufacturers. The FDA issued its official recall request on April 1, 2020. 

Testing Methods

The testing that discovered the “high levels” of NDMA in Zantac involved applying more heat than is present in the human body or in any place a consumer would store the medication. The FDA is asking that future testing include heat levels that are closer to human body temperatures.

Health Consequences

Much of the information reported regarding the Zantac recall sounds a bit scary. But there is no cause for panic. There is no specific information available on the probabilities of developing cancer regarding the short-term use of Zantac. But the chances are more than likely low. Consumers who have been taking Zantac or other medications affected by the recall should have no problem finding a substitute that works just as well for their condition. 

Pending Legal Action

The six class-action lawsuits filed against the makers of Zantac are now one multidistrict litigation action against the companies. The first consideration for consumers who wish to join the multidistrict litigation is demonstrating past use of Zantac. Prescription users of Zantac can show prescription history, and customers who purchased the medicine over the counter will need to produce receipts or other proof of purchase. 

Potential plaintiffs must also show they suffered an injury in some way due to their use of Zantac. This condition can be satisfied with a diagnosis of one of the above-listed cancers. The documentation plaintiffs need to meet this criterion is likely in their medical records. 

The third and most complicated of the three elements is a connection between Zantac and a diagnosed medical condition. Potential plaintiffs may be able to satisfy this requirement by demonstrating long-term use of Zantac. Another possibility is showing a history of high Zantac doses in the months or years leading up to a cancer diagnosis.

Annika Bansal

Annika "The Chick Geek" is the founder of AnnikaBansal.com. Small Business Sense shares small business ideas, tips and resources for independent Entrepreneurs and Small Business owners.