Zantac has been recalled on three separate occasions. In each instance, a voluntary request was made by the Food and Drug Administration (FDA) for either a complete recall or a recall of specific versions of the drug. For thousands of Americans, these recalls came only after life-altering cancer diagnoses.
Introduced as a heartburn medication in the 1980s, Zantac quickly became one of the best-selling products on the market. Millions of Americans turned to the drug for relief. As thousands of these Americans were diagnosed with cancer, investigations into the drug’s safety brought unsettling findings to the surface and prompted the FDA to issue a series of product recalls.
Zantac Recalls in the United States
The Food and Drug Administration routinely tests the medications it approves. As technology improved and more comprehensive testing was enabled, safety issues with Zantac products surfaced.
It was discovered that NDMA, a known carcinogen, found in many ranitidine medications can potentially cause cancer, according to The Oncologist. In response to these discoveries, Zantac has been recalled a number of times.
Overview of Zantac Recalls
- April 1, 2020: The FDA requests a mandatory recall of all prescription and over-the-counter ranitidine drugs.
- September 26, 2019: The FDA announces a voluntary recall of a number of over-the-counter Zantac products, including those manufactured by Apotex Corp. and those labeled by Walgreens, Walmart, and Rite Aid.
- September 24, 2019: The FDA announces the voluntary recall of 14 batches of prescription ranitidine products manufactured by Sandoz Inc.
If you regularly used a prescription or over-the-counter Zantac product prior to recall dates, you may have been exposed to unsafe levels of NDMA. A Zantac lawsuit attorney can review the details of your Zantac use to assess eligibility for a Zantac lawsuit.
Ranitidine, NDMA Contamination, and Cancer
After following a number of cases of patients diagnosed with cancer after taking Zantac, doctors reported that an alarming number of these patients had no family history or genetic markers that would predispose them to a cancer diagnosis. Instead, doctors determined the cause to be environmental and began investigating environmental factors that may have triggered the illness.
NDMA—or N-Nitrosodimethylamine—has been labeled a “probable human carcinogen” by both the FDA and the Environmental Protection Agency (EPA).
Considered non-toxic at low levels, the NDMA levels found in Zantac and over-the-counter ranitidine products exceed those considered safe. Prolonged use of these products has been linked to a number of injuries and illnesses.
Cancers Linked to NDMA in Ranitidine Products
- Bladder cancer
- Colon cancer
- Ovarian, breast, and prostate cancers
- Esophageal cancer
- Kidney and liver cancer
- Stomach cancer
Additionally, NDMA exposure has been linked to Primary Pulmonary Hypertension and Crohn’s Disease. According to FDA guidelines, your daily intake of NDMA should not surpass 96 nanograms. In the case of Zantac and over-the-counter ranitidine products, a single dose of the medication exceeds this daily limit.
While it was originally believed that the dangerous NDMA levels were the result of the temperatures the products were exposed to during shipping and handling, further tests indicate unsafe levels of NDMA in all ranitidine products—regardless of storage temperature. Furthermore, studies indicate an increase in NDMA levels as products age. The older the ranitidine product is, the higher the levels and the greater the risk to you.
NDMA Contamination and Zantac Lawsuits
As increasing numbers of Zantac users found themselves facing cancer diagnoses, investigations into whether manufacturers were aware—or should have been aware—of the dangerous levels of NDMA in ranitidine began. As a result, thousands of lawsuits have since been filed.
Zantac lawsuits claim manufacturers knowingly placed a potentially dangerous product on the shelves without clearly warning consumers of the associated risks and side effects.
Let Chalik & Chalik Injury Lawyers Help You with Your Zantac Lawsuit
If you have been diagnosed with cancer and believe your Zantac use contributed to your illness, Chalik & Chalik Injury Lawyers can advise you on how to proceed.
The initial consultation is free of charge, and all additional services are provided on a contingency-fee-basis—meaning we collect nothing until you win. Call (855) 529-0269 to get started.