Zantac Recall

Sandoz was the first company to issue a voluntary generic Zantac recall on Sept. 24, 2019. Other generic manufacturers soon followed, including brand name Zantac drug maker Sanofi.

Manufacturers are no longer selling brand name or generic Zantac with ranitidine in the United States.

In addition to the U.S., dozens of other countries and jurisdictions have responded to the news of contamination by issuing bans, recalls or warnings.

Zantac recalls from individual companies started in September 2019. The FDA issued the April 2020 market withdrawal because it found that levels of NDMA in ranitidine increase over time when the drug is stored under normal conditions. These levels increase significantly when stored at higher temperatures.

Normally, low levels of NDMA do not affect people, but higher levels could increase the risk of cancer. It’s important to note that taking ranitidine might increase your cancer risk, but it doesn’t mean you will get cancer.

These Zantac recalls don’t affect Sanofi’s OTC formula of Zantac360 that contains famotidine. FDA tests have not found NDMA in famotidine.

The events leading up to the Zantac recall started on Sept. 9, 2019, when the online pharmacy Valisure told the FDA it found NDMA in samples of generic and brand name Zantac.

After the FDA conducted more testing, the agency issued a request for all manufacturers to withdraw all ranitidine products from the market because of NDMA dangers.

As of April 2020, all Zantac manufacturers have withdrawn their ranitidine products from the market, including generics and store brands.

For more details on lot numbers for companies that announced recalls, please check the FDA’s ranitidine recall updates and press announcements page. You can also check with your local pharmacist.

Food and water have some levels of NDMA, but typically the levels are not enough to cause harm. However, according to Valisure’s data, a single tablet of Zantac may contain amounts of NDMA several thousand times more than is safe.

Ranitidine is not the first drug to be recalled because of NDMA contamination. In July 2018, the FDA announced valsartan recalls because several batches of the drug contained NDMA.

According to the Environmental Protection Agency, animals exposed to the chemical have developed tumors in the liver, blood vessels, kidneys and respiratory tract.

NDMA is a “probable human carcinogen.” This means it is a potent carcinogen in animals, but there aren’t enough studies to verify its carcinogenic effect on humans.

Learn about valsartan’s recall over NDMA contamination

The Zantac recalls and market withdrawal have led thousands of people to file Zantac lawsuits against manufacturers including Pfizer, Sanofi and Boehringer Ingelheim.

Lawsuits claimed that Zantac caused various types of cancer in people who used the drug. Bladder cancer was the main type of cancer being accepted in these cases. Cases claimed drugmakers knew about Zantac’s cancer risks but did not warn the public and that ranitidine has design defects.

As of Dec. 15, 2022, there were over 2,000 lawsuits pending in federal court in Florida and hundreds more in state courts. Joseph Baker’s case was the first scheduled to go to trial in Illinois, but he dismissed his case days before the trial in Aug. 2022. Reportedly, several generic manufacturers had offered settlements totaling $500,000 in the months leading to trial.

In December 2022, a judge dismissed all the cases in the Florida MDL, citing a lack of quality evidence. Plaintiffs are appealing.

Types of Cancer Linked to Zantac

Cancer is not one of the typical Zantac side effects. But the NDMA in the drug may increase the risk of several types of cancer.

Studies have linked ranitidine to elevated diagnosis rates of several types of cancer, but so far scientists haven’t definitively said that Zantac causes cancer.

The FDA has determined that NDMA levels increase in some ranitidine products over time. The agency found NDMA levels were greater when more time had passed since the drug was manufactured.

New FDA studies also confirmed significant increases in NDMA levels when samples were stored at higher temperatures. Levels increased under normal storage conditions and at temperatures products may be exposed to during distribution and handling by consumers.

“These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” the FDA concluded.

What Did Earlier FDA Tests Find?

Based on its initial tests, the FDA said NDMA levels in ranitidine were “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

The agency measured NDMA in samples of ranitidine in parts per million. Several lots tested from different manufacturers contained NDMA levels higher than the recommended daily limit of 0.32 ppm.

“The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels,” the agency said about its earlier tests. “At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines.”

The FDA continued its investigation, and in September 2019, the agency warned the public of the potential risks and urged patients and consumers to consider other treatment options.

In its April 2020 announcement, the FDA said the new studies raised concerns that use of ranitidine may expose consumers to unacceptable levels of NDMA.

Levels of NDMA in Initial FDA Tests

The FDA has issued an immediate market withdrawal, and there won’t be any more products with ranitidine on the market in the U.S.

Because of the potential for increased cancer risk, the FDA does not think it’s safe to continue taking ranitidine products. If you are taking prescription ranitidine, don’t stop taking it without speaking to your doctor.

If you have any questions about your cancer risk or are worried about cancer symptoms, please talk to your health care provider.

Zantac Alternatives

FDA-recommended alternatives to Zantac include: Prilosec (omeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Pepcid (famotidine) and Tagamet (cimetidine).

Sanofi recently released a new OTC formula for Zantac360 made with famotidine instead of ranitidine.
In addition to medications, some patients may be able to control mild heartburn with diet and lifestyle changes.