Recently, a class-action lawsuit has been filed against the makers of Zantac, an over-the-counter heartburn medication. The lawsuit claims the drug contains excessive levels of N-Nitrosodimethylamine (NDMA), which has been known to cause cancer. 

The FDA reported that NDMA had contaminated the active ingredient in Zantac, ranitidine. The levels the FDA reported were 3,000 to 26,000 times higher than the standards set and approved by the FDA. 

NDMA is believed to be a hepatotoxic, and exposure to NDMA has been linked to a variety of medical complications including:

  • Bladder cancer
  • Stomach cancer
  • Liver fibrosis
  • Liver scarring
  • Lung, kidney, and liver tumors

Minor symptoms of NDMA exposure can include: headaches, nausea, fever, jaundice, abdominal cramps, vomiting, dizziness, enlarged liver, reduced kidney function, as well as reduced liver and lung function. 

The plaintiffs in the class-action lawsuit are accusing Zantac drug manufacturers Sanofi and Boerhringer Ingelheim of manufacturing and distributing the toxic, cancer-causing medication to consumers without disclosing the potential risks. 


Zantac is the commercial name for the Ranitidine, a well-known medicine that helps to reduce the amount of acid produced in the stomach. The medication is most commonly used as a treatment for ulcers, indigestion, and heartburn. It has also been known to prevent ulcers, treats gastroesophageal reflux disease, and Zollinger-Ellison syndrome. 

Zantac is available in both prescription and an over-the-counter form. The active ingredient Ranitidine is a histamine blocker and over-the-counter Zantac is most commonly used to treat heartburn, while the prescription form of the drug is used to prevent ulcers and other abdominal issues. The drug has been around since 1981 and is the 50th most commonly prescribed medication in the United States. 

FDA Warning

On September 13th, 2019, the FDA reported finding NDMA in ranitidine. The FDA establishes acceptable limits of ranitidine at below 100 nanograms for individuals. In the class-action lawsuit, the plaintiffs claim that a single 150mg pill of Zantac contains over 2.5 million nanograms of ranitidine. When you take into consideration that the recommended treatment of an adult peptic ulcer is 300mg, it is easy to see where the carcinogenic contamination can occur. 

The plaintiffs allege that Sanofi and Boehringer Ingleham knew the risks to consumers and still failed to alert the public, either through warnings on labels or other means. There have been a variety of medical studies that show users of ranitidine have 400 times the safe amount in their urine. The lawsuit claims, that if given proper warning, many individuals would choose to not use Zantac or a generic version to treat their ailments. 

Cancer Risk

The studies by the FDA and the World Health Organization have described NDMA as carcinogenic. The FDA is currently working with the industry and regulators to determine the impurities within ranitidine and how NDMA is potentially harmful to patients. Since the investigation is still ongoing, there have been no specific actions taken at this time. 

Recall of Zantac

As of right now, there has not been an active recall of Zantac, nor has the FDA told patients to stop taking ranitidine. Some of the larger chain stores like Walmart and CVS have chosen to no longer carry the product because of the potential cancer risk to customers until the results of the investigation are published. 

At this point in the study, it has not been proven that NDMA levels in the drug are high enough to cause cancer. As of right now, NDMA is classified as a “probable carcinogen,” which means that a patient would need prolonged exposure to high doses of the chemical over a long period of time. 

The FDA is recommending that patients talk to their health care provider to seek an alternative treatment. They do not recommend long-term use of ranitidine. There are a variety of other drugs on the market that do not have NDMA impurities in their products. There has not been any evidence to support other heartburn medications are affected by the impurities found in Zantac. 

Zantac Lawsuits

There have been class-action lawsuits filed against the manufacturers of Zantac, which allege that users of the product have been exposed to unsafe levels of NDMA by taking the medication. If you have taken Zantac and have been diagnosed with stomach or bladder cancer, you might be entitled to the following compensation:

  • Medical expenses that resulted from your illness
  • Lost wages
  • Lost future earning potential
  • Pain and suffering from your medical treatment
  • Changes to your quality of life
  • Other punitive damages

A successful lawsuit can help people who have been devastated by large medical bills, and changes to their quality of life get back some of the money lost through medical treatment, lost earnings, and other expenses associated with fighting cancer. Along with the monetary damages, a class-action lawsuit can ensure that the proper warnings and protections are put in place to keep other consumers from falling victim to substandard practices. 

All consumers and health care professionals should report any and all exposure from ranitidine to the FDA through their MedWatch program. This helps the FDA in their research of the drug and the potential carcinogenic and other hazardous impacts on consumers. 

Zantac Lawsuit Process

A Zantac lawsuit is the same basic process as filing any other personal injury lawsuit. There are some basic steps in this process that anyone looking to file a suit should familiarize themselves with. These steps include:

  • Hiring an experienced attorney with experience handling these types of cases
  • If you have lost a loved one as a result of the exposure, then you might be eligible to file a wrongful death lawsuit
  • Identify, with the help of your attorney, the liable parties
  • Gather evidence 
  • Prove the total cost of all losses, including current and future medical expenses
  • Your attorney will help you file for compensation and punitive damages
  • Filing the complaint 
  • Negotiating a settlement offer 
  • Litigating your case in court (if necessary)

Benefits of an Experienced Attorney

The process of filing a lawsuit, especially a class-action lawsuit, against a large corporation can be complicated and time-consuming. An experienced mass tort attorney can help you to navigate the entire process and make sure your claim is thoroughly completed. 

Contact Gary Falkowitz today for your free Zantac lawsuit case evaluation.