Zantac/Ranitidine Lawsuit

Zantac (ranitidine) Linked to Cancer:

The U.S. Food and Drug Administration requested on April 1, 2020 that all manufacturers withdraw all Zantac and generic Zantac OTC ranitidine drugs from the market immediately. The FDA determined that N-Nitrosodimethylamine (NDMA) in some ranitidine medications “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…”

FDA Alert | Carcinogenic Impurity Found in Samples of Ranitidine:

On September 13, 2019, The U.S. Food and Drug Administration (FDA) alerted patients and healthcare professionals that they found some Zantac/Ranitidine medicines contain NDMA (N-nitrosodimethylamine) which is a known carcinogen. [2]

NDMA Background

NDMA is a cancer-causing semi-volatile organic chemical. It is not currently produced in the United States or used commercially except for cancer research to induce tumors in laboratory animals.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines since last year. In the case of these blood pressure and heart failure medications, the FDA has recommended numerous recalls as it discovered nitrosamine levels that were unacceptable and posed a risk to patients.[2]

NDMA as a Carcinogen

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.  [3]

The FDA’s investigation into NDMA found in samples of Zantac and Ranitidine is ongoing.

For the most up-to-date information about NDMA in Zantac (ranitidine) visit the FDA website.

About Zantac (ranitidine):

Zantac, generically known as ranitidine, has been sold in the United States since the 1980s. It is a histamine H2-receptor antagonist also known as a H2 blocker, which decreases the amount of acid produced by the stomach. People commonly use Zantac to treat ulcers, heartburn, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, Barrett’s esophagus and other medical conditions caused by the excessive production of stomach acid. [1] [2] Zantac can also be used by some as part of their allergy treatment protocol.

Zantac Recall LawsuitZantac, the name brand drug, became available as an over the counter (OTC) medication in 2004. Zantac was available in varying dosages and forms including tablets, effervescent tablets and granules as well as a liquid. [1] By the end of the 1980s, Zantac became one of the world’s best-selling drugs and one of the first to generate $1 billion in sales. The generic version of Zantac known as ranitidine became available after Glaxo Holdings’ (now known as GlaxoSmithKline) patent expired in 1997. Generic versions of the drug were sold at pharmacies and stores throughout the United States for decades. All Zantac and generic ranitidine drugs have now been withdrawn from the market.

Get Help Now:

Exposure to NDMA can cause cancer. Injuries from NDMA exposure include but are not limited to:

  • Breast Cancer
  • Testicular Cancer
  • Bladder Cancer
  • Thyroid Cancer
  • Kidney Cancer
  • Melanoma
  • Prostrate Cancer (Under age of 65)
  • Uterine Cancer
  • Intestinal Cancer
  • Liver Cancer
  • Esophageal/Nasal/Throat Cancer
  • Lung Cancer (for non-smokers)
  • Ovarian Cancer
  • Pancreatic Cancer
  • Stomach Cancer

If you have been taking the medication Zantac and are suffering from any of the cancers listed above, you may be entitled to compensation. Click, Chat or call 1800LAW1010 24/7 for a free case evaluation.

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Recalls of Ranitidine

Recent Update:
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. [23]

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. [5] Shortly thereafter, on September 25, 2019, Apotex Corp. issued a nationwide recall of Ranitidine Tablets 75mg and 150mg. [6]  The cause of the contamination is still under investigation. [7]

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. [9] 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®. [10]

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. [11] Novitium Pharma LLC voluntarily recalled all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine. [12] 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. [13]

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. [14]

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. [15] 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. [16]

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. [17]

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. [18]

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. [19]

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. [20]

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.  [21]

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. [22]

  1. MedlinePlus (2015, November 15) Ranitidine. Retrieved from https://medlineplus.gov/druginfo/meds/a601106.html
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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 
  16. 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
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. 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
  23. 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