Zantac (ranitidine) Linked to Cancer:
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FDA Alert | Carcinogenic Impurity Found in Samples of Ranitidine:
If you developed cancer after taking Zantac, you may be entitled to significant compensation. Zantac, and its generic equivalent known as ranitidine, is a popular medication commonly used to treat heartburn. Pharmaceutical company GlaxoSmithKline first developed Zantac in 1977. It was approved by the FDA in 1983, and has been available as a generic since 1994. Various drug manufacturers have sold Zantac and over-the-counter ranitidine.
Studies have shown the presence of a carcinogen in Zantac known as NDMA, which is linked to causing cancer. The U.S. Department of Health and Human Services (DHHS) has stated that NDMA is reasonably anticipated to be a human carcinogen. DHHS has also stated that NDMA causes tumors in numerous species of experimental animals at various tissue sites. Tumors in animals primarily occurred in the liver, respiratory tract, kidney, and blood vessels.  It is not currently produced in the United States or used commercially except for cancer research to induce tumors in laboratory animals.
In the fall of 2019, the FDA learned that there was an unacceptable amount of NDMA in some samples of Zantac and ranitidine. On April 1, 2020, the FDA announced that all Zantac brand heartburn drugs, prescription and over-the-counter, should be immediately removed from the market because of a risk to public health due to potential NDMA contamination.
No one is ready to hear that the medication they trusted and took regularly for years has high levels of carcinogens in it. And when a cancer diagnosis follows, you may not only feel resounding anger, but helpless in the face of the large pharmaceuticals responsible for your cancer. You are not helpless, however, and there is hope.
The attorneys at Harding Mazzotti, LLP have years of experience fighting deep-pocketed corporations. We understand just how complex defective drug cases can be, and we have the skills and resources needed to build the strongest case possible. You deserve dedicated, qualified legal representation for your case. Contact us today at 1-800-LAW-1010 (1-800-529-1010) for a free consultation.
What is Zantac?
Zantac, otherwise known as ranitidine, reduces the production of stomach acid. It treats and prevents stomach and intestine ulcers. It’s also effective in treating gastroesophageal reflux disease (GERD), peptic ulcer disease, heartburn, and acid indigestion. The drug is available by prescription and over the counter from over 20 different manufacturers.
Zantac/Ranitidine belongs to a class of drugs known as h2 (histamine-2) blockers. The OTC version of Zantac is popular in relieving and preventing heartburn, while the prescription-strength version is prescribed to prevent ulcers and other serious medical conditions.
FDA Warnings: Zantac and NDMA
The U.S. Food and Drug Administration (FDA) warned consumers of a carcinogen found in Zantac. Studies showed NDMA in Zantac and ranitidine medications were at levels thousands of times higher than standards approved by the FDA.
Current civil lawsuits allege that the pharmaceutical companies manufacturing and selling Zantac and ranitidine defectively designed and manufactured the drug, and knew of the risks, but failed to alert its consumers through warning labels or other means. If users had known of the potential for developing cancer, they would not have taken Zantac.
Exposure to NDMA causes symptoms, such as:
- Abdominal cramps
NDMA exposure can potentially cause various forms of cancer and other medical problems, including but not limited to:
- Bladder Cancer
- Esophageal Cancer
- Gastric Cancer
- Liver Cancer
- Pancreatic Cancer
Immediately after studies showing dangerous levels of NDMA in Zantac surfaced, retailers pulled the product from their shelves. However, the FDA didn’t issue an immediate recall. Manufacturers continued to make the drug, and some companies continued to sell it.
After further studies and a thorough investigation, the FDA finally ordered all manufacturers to remove both prescription and OTC ranitidine drugs from the market on April 1, 2020. They also advised consumers to stop taking over the counter Zantac and ranitidine, dispose of the medication properly, and not buy more. For patients taking prescription ranitidine, the FDA encouraged patients to speak with their health care professionsl about other treatment options as there are multiple drugs approved for the same or similar uses that do not carry the same risks from NDMA. Notably, the FDA stated that NDMA is not in Pepcid, Tagamet, Nexium, Prevacid, or Prilosec.
How to Hold the Drug Companies Responsible
If you want to pursue a financial award in a lawsuit against the manufacturer of Zantac, there’s a strict deadline you must follow. The statute of limitations for a defective drug lawsuit varies by state. It’s typically between one and five years. The statute limits how long after your cancer diagnosis you have a right to sue for damages. If you do not commence a lawsuit before your statute of limitations expires, you lose your right to bring a case.
Compensation Available in a Zantac Cancer Lawsuit
If you choose to file a lawsuit against the makers of Zantac, you could potentially win a financial award that covers your past and future damages. Compensatory damages are the expenses and suffering resulting from someone else’s negligence. Compensatory damages fall under two categories: economic and non–economic. The damages you could pursue in a Zantac lawsuit include the following: past and future medical expenses, loss of income and lost future earnings, physical pain, emotional distress, physical impairment or disability, loss of enjoyment of life, and loss of companionship or consortium.
Why You Should Choose Harding Mazzotti, LLP
Partner Rosemarie Riddell Bogdan is one of a select group of attorneys in the country that has been appointed by the U.S. District Court to the Plaintiffs’ Steering Committee in the In re: Zantac (Ranitidine) Products Liability Litigation. The Plaintiffs’ Steering Committee is the leadership structure for plaintiffs whose role is representing the common interests of all plaintiffs in the litigation. Ms. Bogdan’s leadership role in this litigation positions Harding Mazzotti LLP to effectively advocate for your rights.
Harding Mazzotti LLP has proudly represent injured individuals for over 25 years. Our dedication to our clients is what sets us apart from other law firms. We care about you and when you hire us, you will be a priority.
We provide legal services you can depend on. Developing cancer is a devastating experience, and the effects are even worse when you find out it’s from a drug you thought was helping you. We know the pain and trauma you’re going through, and it’s our goal to help you fight for the compensation you deserve.
You can contact us for a free consultation if you want to pursue legal action against the makers of Zantac or ranitidine. Call Harding Mazzotti, LLP today at 1-800-LAW-1010 to find out how we can help you if you took Zantac and received a cancer diagnosis.
Recalls of Ranitidine
On April 1, 2020, The FDA requested the immediate withdrawal of all Randitidine products (Zantac) from the market. This is the latest step in an ongoing investigation of the contaminant NDMA. 
On September 23, 2019, drug manufacturer Sandoz Inc. issued a recall of ranitidine hydrochloride capsules at 150 mg and 300mg due to an elevated amount of the impurity NDMA, which is classified as a possible human carcinogen.  Shortly thereafter, on September 25, 2019, Apotex Corp. issued a nationwide recall of Ranitidine Tablets 75mg and 150mg.  The cause of the contamination is still under investigation. 
On October 23, 2019, the FDA alerted patients and health care professionals to two voluntary recalls of ranitidine. Dr. Reddy’s Laboratories Ltd. issued a voluntary recall on all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.  Drug manufacturer Sanofi also initiated a voluntary recall of all Zantac OTC in the United States, including Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. 
On October 28, 2019, the FDA announced to health care professionals and patients three voluntary recalls of ranitidine. Perrigo Company plc voluntarily recalled OTC ranitidine tablets (all pack sizes) due to the potential of NDMA in the medicine.  Novitium Pharma LLC voluntarily recalled all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine.  Lannett Company, Inc. also voluntarily recalled all unexpired lots of prescription ranitidine syrup (ranitidine oral solution, USP, 15mg/mL) due to the presence of NDMA found in the drug. 
On November 8th, 2019, the FDA announced a voluntary recall of OTC ranitidine tablets (150mg), prescription ranitidine capsules (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Aurobindo Pharma USA. These medications contain unacceptable levels of NDMA. 
On November 12, 2019, the FDA alerted patients and health care professionals to two voluntary recalls of ranitidine. Amneal Pharmaceuticals LLC voluntarily recalled prescription ranitidine hydrochloride tablets (150mg and 300mg) and ranitidine syrup (15mg/mL) manufactured by Amneal. These medications were found to contain unacceptable levels of NDMA.  American Health Packaging also voluntarily recalled eight lots of American Health Packaging also voluntarily recalled eight lots of ranitidine syrup (150 mg/10 mL) liquid unit dose cups, manufactured by Lannett Company. 
On November 15, 2019, Golden State Medical Supply, Incorporated (GSMS, Inc) announced a voluntary recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to consumers due to the potential presence of NDMA above levels established by the FDA. 
On November 19, 2019, Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to consumers. Ranitidine Oral Solution, USP 150 mg/10 mL, was recalled because of potential NDMA amounts above levels established by the FDA. 
On December 17, 2019, Glenmark Pharmaceutical Inc., USA announced the voluntary recall of all unexpired lots of Ranitidine tablets, 150 mg and 300 mg to consumers. The recalled lots of Ranitidine tablets are being recalled because of the presence, or potential presence, of NDMA levels above the acceptable FDA-established daily intake levels. 
On January 7, 2020, Appco Pharma LLC (Appco) voluntarily recalled all quantities and lots of Ranitidine Hydrochloride Capsules to consumers. These Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of NDMA levels above the acceptable FDA-established daily intake levels. 
On January 9, 2020, Denton Pharma, Inc., an affiliate of Northwind Pharmaceuticals, LLC, announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to consumers. The recall is in response to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged by Denton Pharma, Inc., doing business as Northwind Pharmaceuticals. 
On February 27, 2020, American Health Packaging voluntarily recalled eleven lots of Ranitidine tablets (USP 150 mg, 100 count Unit Dose Blisters) to consumers due to the potential presence of NDMA amounts above levels established by the FDA. 
- MedlinePlus (2015, November 15) Ranitidine. Retrieved from https://medlineplus.gov/druginfo/meds/a601106.html
- U.S. Food & Drug Administration (2019, September 13) Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
- United States Environmental Protection Agency (2017, November) Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA). Retrieved from https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
- World Health Organization. (2008) Guidelines for Drinking-Water Quality, 3rd edition; N-Nitrosodimethylamine (NDMA) Retrieved from https://www.who.int/water_sanitation_health/dwq/chemicals/ndmasummary_2ndadd.pdf
- U.S. Food & Drug Administration (2019, September 23). Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
- Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and
- FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
- FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan
- U.S. Food & Drug Administration (2019, October 23). Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market
- U.S. Food & Drug Administration (2019, October 23). Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us
- U.S. Food & Drug Administration (2019, October 23). Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n
- U.S. Food & Drug Administration (2019, October 25). Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg
- U.S. Food & Drug Administration (2019, October 25). Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral-solution-usp-15mgml-due
- U.S. Food & Drug Administration (2019, November 6). Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine
- U.S. Food & Drug Administration (2019, November 12). Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg
- U.S. Food & Drug Administration (2019, November 8). American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral
- U.S. Food & Drug Administration (2019, November 15). Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-150mg
- U.S. Food & Drug Administration (2019, November 19). Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-ranitidine-oral-solution-usp-150-mg10-ml-due
- U.S. Food & Drug Administration (2019, November 17). Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-voluntarily-recalls-all-unexpired-lots-its-ranitidine-tablets-and?utm
- U.S. Food & Drug Administration (2020, January 7). Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/appco-pharma-llc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-capsules-150-mg-and-300?utm
- U.S. Food & Drug Administration (2020, January 9). Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/denton-pharma-inc-dba-northwind-pharmaceuticals-voluntarily-recalls-all-unexpired-lots-its
- U.S. Food & Drug Administration (2020, February 27). American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150-mg-100-count
- U.S. Food & Drug Administration (2020, April 1). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market