Zantac Lawsuit Information

Saturday September 13, 2025 — The FDA has recalled the popular antacid Zantac due to a heightened risk of cancer.

Serious side effects associated with Zantac, as well as generic ranitidine, include:

• Bladder cancer
• Colon cancer
• Colorectal cancer
• Gastrointestinal cancer
• Kidney cancer
• Liver cancer
• Stomach cancer
• Other cancers

If you or a loved one was diagnosed after taking this medication, you may have a significant legal claim against the drug’s manufacturer.

To speak with an experienced Zantac attorney about your case, contact our firm by phone or online at any time.

We provide all consultations at no cost and with no obligation.

Zantac Cancer Risk

Zantac and generic ranitidine drugs are likely to be contaminated with a substance known as nitrosodimethylamine, or NDMA.

The International Agency for Research on Cancer (IARC) classifies NDMA as “probably carcinogenetic to humans,” the agency’s second-strongest designation.

The FDA recalled Zantac after findings of widespread NDMA contamination in both prescription and over-the-counter ranitidine products.

NDMA is the same chemical impurity that triggered a global recall of the blood pressure and heart failure medication Valsartan in 2018.

The FDA’s Zantac recall was announced on April 1, 2020 following a series of safety investigations and market withdrawals:

• September 9, 2019: Valisure is an online pharmacy that regularly tests its medications for quality control purposes. Through routine testing of Zantac, Valisure discovered “extremely high levels” of NDMA in every lot tested across multiple manufacturers.
• Specifically, while the FDA permits a daily NDMA intake limit of 96 nanograms, Valisure detected more than 3,000,000 nanograms of NDMA per tablet when analyzing ranitidine.
• Accordingly, Valisure submitted a Citizen Petition to the FDA to warn about impurities in Zantac, to notify the FDA that Valisure would discontinue all sales of ranitidine, and to request that the FDA initiate a comprehensive recall of Zantac from the U.S. market.
• September 13, 2019: Following Valisure’s petition, the FDA released a statement alerting patients and health care providers about potential NDMA contamination in Zantac and generic ranitidine.
• Government regulators at Health Canada and the European Medicines Agency issued similar statements, advising that patients may wish to consider alternative treatments for heartburn, stomach acid, ulcers, and gastroesophageal reflux disease (GERD).
• September 28, 2019: Major U.S. pharmacies including CVS, Walgreens, Rite Aid, and Walmart suspended sales of brand name Zantac and generic ranitidine pending the FDA’s further review of safety concerns.
• October 8, 2019: GlaxoSmithKline began a global recall of prescription-only Zantac after a series of government safety warnings.
• October 18, 2019: Sanofi initiated a voluntary recall of all over-the-counter (or, OTC) Zantac products in the United States.
• January 8, 2020: Generic manufacturers Appco Pharma and Northwind Pharmaceuticals recalled additional prescription forms of ranitidine, bringing the total number of recalls to 14 in the preceding five months.
• April 1, 2020: After further studies, the FDA determined that Zantac posed an ongoing risk to public health. The agency announced an immediate removal request for all prescription and over-the-counter Zantac and generic ranitidine.
• FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
• Specifically, the FDA confirmed that NDMA impurities in ranitidine increase over time, and can reach unacceptably high levels even under normal storage conditions.
• As part of the recall, the FDA advised patients, “[T]here 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).”

Zantac Lawsuits Allege Failure to Warn

Zantac lawsuits are now pending on behalf of patients and families of patients diagnosed with cancer after taking Zantac.

The lawsuits allege that manufacturers of ranitidine were aware of the risk posed by NDMA contamination years before the FDA recall, but failed to warn patients, doctors, and government regulators.

Instead, the manufacturers aggressively marketed Zantac, which was once the best-selling drug in the world, accounting for over 16 million prescriptions in 2017 alone.

Factual Background

NDMA is a potent chemical historically used in the manufacture of liquid rocket fuel and additives for lubricants. The only contemporary use of NDMA is to induce cancerous tumors in laboratory animals for research purposes. Both the World Health Organization (WHO) and the U.S. Environmental Protection Agency (EPA) classify NDMA as a probable human carcinogen.

The NDMA impurities found in Zantac and other ranitidine medications were not the result of a manufacturing defect. Rather, researchers found NDMA contamination in samples of ranitidine across all manufacturers, product lines, and storage conditions tested. In addition, ranitidine can cause NDMA formation inside the body when the drug interacts with gastric fluid in the human digestive system. In other words, the dangers posed by Zantac are inherent to the pharmaceutical compound itself.

Prescription Zantac was first approved in the U.S. in 1983 and the drug reached $1 billion in sales by 1986. Since that time, over-the-counter and generic versions have contributed to ranitidine’s widespread use and unprecedented market success.

As early as 1981, however, scientific evidence showed elevated levels of NDMA in Zantac. This information was publicly available and known to the drug’s manufacturers. Despite this knowledge, the defendants continually failed to report these findings to the FDA while exposing millions of Americans to a heightened and unnecessary cancer risk for decades.

Defendants

• Sanofi S.A.
• Pfizer, Inc.
• Boehringer Ingelheim Pharmaceuticals, Inc.
• GlaxoSmithKlinem, LLC
• Walgreens
• Walmart
• Rite-Aid
• CVS

Causes of Action

1. Strict Products Liability – Design Defect. Zantac’s design is defective and poses an unreasonable risk of harm to patients even when properly manufactured.

2. Strict Products Liability – Failure to Warn. Zantac’s design is additionally defective because the drug label does not warn consumers about potential NDMA contamination and the risk of cancer.

3. Negligence. The manufacturers of Zantac breached their duty to exercise reasonable care in the course of developing medical products and marketing them to consumers.

4. Breach of Express Warranties. Defendants expressly represented to consumers that Zantac was safe and effective for its intended uses despite a known cancer risk from NDMA.

5. Breach of Implied Warranties. Defendants made implied warranties to consumers and the public that Zantac was safe, effective, and of merchantable quality despite known health risks.

6. False Advertising. The defendants marketed Zantac as safe and effective, intentionally misleading consumers.

7. Fraud. Defendants’ false statements regarding the safety of Zantac, as well as their omission of important safety warnings, were willful and intended to deceive consumers, health care providers, and government regulators.

Zantac Lawsuit FAQs

Is the Zantac lawsuit a class action proceeding? No. As with other pharmaceutical cases, claims by Zantac victims will be filed on an individual basis. This means you will have your own attorney to represent you, and your case will be resolved according to the unique facts of your case and the damages you experienced. In a class action, by contrast, a select few plaintiffs would file a single lawsuit on behalf of all victims with any recovery generally divided amongst the class members. No such class has been certified on behalf of Zantac users. At the same time, your individual claim will be coordinated with other claims for pretrial purposes as part of the Zantac Multidistrict Litigation (MDL No. 2924) now proceeding in the U.S. District Court for the Southern District of Florida.

How do you join the lawsuit? The first step is to consult an experienced pharmaceutical injury attorney about your potential claim and what to expect from the litigation process. Our attorneys provide consultations at no cost, the information you discuss is treated as confidential, and you will not be obligated to pursue your case unless you choose to do so.

Will you have to pay legal fees or expenses? No. we represent Zantac clients under a contingency fee arrangement. This means you do not pay any attorneys’ fees, case costs, or litigation expenses out of pocket. Instead, we recover fees as a percentage of the amount recovered on your behalf and only if your case is successful. We invite your questions about our firm’s contingency fee policy and any financial concerns you might have about pursuing a claim.

Has a settlement been reached to compensate Zantac users? No. The Zantac litigation is still in the early stages. While your attorneys will be working diligently to reach a settlement with the defendants, the number of claimants and complexity of the case will require additional time to resolve.

What is the deadline for filing a claim? As with any legal case, certain time restrictions will apply to your claim (known as the statute of limitations). We encourage Zantac users to consult an attorney in a timely manner. An attorney can advise you of any upcoming deadlines, help you document your damages, and offer other guidance as your case proceeds.

Review Your Zantac Lawsuit with an Attorney

If you or a loved one was diagnosed with cancer after using Zantac or generic ranitidine, you may be entitled to compensation for your legal damages. Contact our Zantac attorneys by phone or through our brief online form to discuss your case and learn how we can help.