Zantac/Ranitidine Lawsuit

Recalls of Ranitidine

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]

About Zantac (ranitidine):

Zantac Lawsuit

Zantac, generically known as ranitidine, is an H2 (histamine-2) blocker, which decreases the amount of acid produced by the stomach. Zantac is available as an over the counter (OTC) and prescription medication. [1] [2]

The OTC version is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Zantac is used to treat ulcers; gastroesophageal reflux disease (GERD); conditions where the stomach overproduces acid, such as Zollinger-Ellison syndrome; and other conditions. [1] [2]

Zantac is available as:

  • A tablet
  • An effervescent tablet
  • Effervescent granules
  • A syrup to take by mouth  [1]

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 a nitrosamine impurity called N-nitrosodimethylamine (NDMA) was found in samples of ranitidine medicines at low levels. [2] While the advisory calls the levels “low,” the levels of contamination that  have been found to be 3,000 to 26,000 times higher than what the FDA has deemed to be “safe.” [8]

NDMA Background

NDMA is a cancer-causing semi-volatile organic chemical that can be produced as a by-product of several industrial processes [3]. NDMA is known as an environmental contaminant and is found in low levels in water and foods, including meats, dairy products, and vegetables. [2]  It is a component of rocket fuel and industrial lubricants.  It is also used in cancer research to induce tumors in laboratory rats.

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 levels that were unacceptable. [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 has caused tumors in numerous species of experimental animals at various tissue sites. Tumors 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.

Get Help Now:

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

  • Stomach Cancer
  • Intestinal Cancer
  • Bladder Cancer

If you have been taking the medication Zantac and are suffering from stomach, intestinal, or bladder cancer, you may be entitled to compensation. Click, Chat or call 1800LAW1010 24/7 for a free case evaluation.

  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