Zantac is a popular heartburn medication that has recently been the subject of multiple recalls. The recall on Zantac has caused consumers who use, or have used, the medication to be concerned about ramifications on their health. Zantac’s maker has pulled the brand-name product off the shelves, and makers of the drug’s generic version, ranitidine, have also instituted recalls. Consumers may be wondering: why is there a recall on Zantac, and what should we do about it?

What is Zantac?

Also known by its generic name, ranitidine hydrochloride, Zantac is a histamine-2 blocker, a drug that works to prevent heartburn by reducing the amount of stomach acid.

In addition to treating heartburn, Zantac is also used for related conditions including Gastroesophageal Reflux Disease (GERD), ulcers, and Zollinger-Ellison syndrome. Zantac is manufactured and distributed by Sanofi.

Why is there a recall on Zantac?

So why is there a recall on Zantac, and what exactly is the big deal? Zantac may have been contaminated by NDMA (N-nitrosodimethylamine), a possible human carcinogen, so some manufacturers are taking it off the shelves to best protect patients. According to the World Health Organization, high levels of NDMA can lead to gastric or colorectal cancer.

NDMA is an environmental contaminant and is most often found in the soil, water, or foods. The chemical was reportedly used in the past to make rocket fuel, although the EPA now limits its usage for research purposes only.

Unfortunately, there are concerns that NDMA could be produced as a byproduct of manufacturing processes or through the chlorination of drinking water. This unintentional contamination may lead to NDMA being found in unexpected places.

Though NDMA is a common substance, even found in some foods, the concern is that Zantac may have been contaminated with dangerous levels of the chemical, explains The Deseret News.

The first recalls of Zantac were initiated voluntarily — meaning that manufacturers started the recall process themselves instead of having a recall mandated by a regulator such as the U.S. Food and Drug Administration (FDA). On Dec. 4, 2019, the FDA said it had asked manufacturers of ranitidine to test all lots of the medication for NDMA contamination before the drugs are available to consumers. The FDA has advised companies to recall their medications if they find NDMA exceeding 96 nanograms in a single day or 0.32 parts per million.

But is there a recall on Zantac products without proof of NDMA contamination?

In some cases, drugstores stopped selling the drug in order to protect their consumers. Stores such as CVS, Walmart, and Walgreens took their own ranitidine medications off the market and pulled other related medications from their shelves.

Moreover, following the initial voluntary recall on Zantac, the FDA stepped in. In April 2020, the FDA called for all brand name and generic Zantac products to be removed from the market immediately until the source of the contamination can be discovered and controlled.

Should I throw away my medication following the recall on Zantac?

Although Zantac recalls could be concerning, the FDA stresses the importance of staying with a treatment plan until a replacement can be found by a pharmacist or physician. As always, the regulator does not recommend making treatment changes based on recalls and instead urges patients to speak with their healthcare team about any concerns they may have.

Is there a recall on Zantac? Yes, but it is important to also keep in mind that changes to your treatment should always be overseen by your doctor to avoid unnecessary risk.

There are potential alternatives, however, that you may want to speak with your doctor about. The FDA says testing of samples of Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) have not shown NDMA contamination. These drugs are all over-the-counter alternatives to ranitidine, which is also available in prescription strengths to treat ulcers, heartburn, and acid reflux problems.

How was Zantac contaminated?

Some people may be wondering: why is there a recall on Zantac even if the products haven’t been found to contain NDMA? The Deseret News explains that recent research has provided insight into how the drug may have become contaminated in the first place. An Emery Pharma study found that NDMA could be created when ranitidine is exposed to too much heat. According to chemist Ron Najafi, “NDMA in this case … is not an impurity in the drug, it’s being formed from the drug itself.” 

The FDA’s acceptable daily limit of NDMA is 96 nanograms, according to CBS News. The recent study showed that when left at room temperature for 12 days, the amount of NDMA present in the ranitidine rose to 25 nanograms — well below the FDA’s level. However, when heated to 158 degrees, the amount of NDMA found in the ranitidine rose to 142 nanograms — substantially above the FDA’s limit. A temperature of 158 degrees can easily be reached if, for example, the medication was left in a hot car in summertime, according to CBS News. At this temperature, NDMA will likely form.

Even with the new information provided by the study, there are questions still unanswered, The explained Dr. Janet Woodcock, the FDA’s head of drug evaluation and research. Reportedly, whether ranitidine needs to be kept cold to keep the drug from converting into NDMA has yet to be studied.

The FDA is also investigating if the drug could be converted into NDMA once it has been ingested, reports CBS News, and why more NDMA was found in some batches of ranitidine than others. For its part, name-brand Zantac maker Sanofi is testing its products and has implemented a recall. Some other drugmakers have recalled generic versions of Zantac.

NDMA has been found in other drugs as well, per the Deseret News, including blood pressure medication valsartan. The valsartan recall was later expanded to include losartan and irbesartan.

How are consumers responding?

Newsweek speculated in October 2019 that the recall on Zantac could prompt a class action lawsuit, and experts thought through what that might entail.

Reportedly, other drugs may have been contaminated by NDMA as well, a discovery which has prompted recalls. In these cases, class action lawsuits are being considered, explains Newsweek. Because these drugs are mass produced, a class action lawsuit could be a good way to seek justice for many and possibly get compensation into the hands of people who need it.

Now, experts wonder if the same will happen in light of news that Zantac may have been contaminated. According to Visiting Professor of Law at Case Western Reserve University School of Law Katharine Van Tassel, it is too early to tell, reports Newsweek.

In her eyes, there does not seem as if there is enough evidence to establish that the presence NDMA in ranitidine (Zantac products) could cause cancer. Reportedly, others in the field agree, including Michael D. Green, Professor of Law at Wake Forest University School of Law. He summarized, saying “the dose makes the poison,” stating that “it’s important to find out what the dose is” to determine if there is enough of the contaminant in the medication to pose a risk to patients.

Dr. Van Tessel went on to explain why making a claim over Zantac could be challenging. She noted that the burden of proof would be on a patient to show that a case of cancer was linked to their use of Zantac, as opposed to due to another factor in their life. She stated that in some cases, this requires linking 51 percent of factors in their case to the use of Zantac as opposed to other factors.

Despite Dr. Van Tessel’s doubts, a number of individual and class action lawsuits have been filed by patients who allege they developed bladder or liver cancer or are now at an increased risk of cancer from ingesting contaminated generic Zantac over an unknown period of time.

According to one Zantac lawsuit filed by a victim and his wife, the manufacturers of Zantac may have been aware for years of the potential contamination. According to plaintiff Douglas R., who filed his lawsuit against several ranitidine manufacturers in April, the drugmakers may have been aware of the potential dangers associated with the carcinogen contaminant, but failed to inform the FDA of these risks.

He claims that Sanofi put profits above people for years, and may have exposed millions of victims to chemicals that could cause cancer. Douglas developed a rare form of bladder cancer after regularly taking Zantac.

Several other plaintiffs in states including Illinois, Ohio, New Jersey, and Colorado have also filed lawsuits against the drug manufacturers after developing conditions such as gastric or stomach cancer, bladder cancer, colorectal cancer, kidney cancer, prostate cancer, and esophageal cancer.

The victims in these cases are seeking compensation for their injuries, pain and suffering, and medical expenses, as well as additional punitive damages against the manufacturers.

Filing a Zantac lawsuit

If you or someone you love has been diagnosed with cancer after exposure to Zantac, you may be able to file a lawsuit and pursue compensation. Filing a lawsuit cannot take away the pain and suffering caused by a cancer diagnosis, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

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