UPDATE: FDA Requests Removal of All Ranitidine (ZANTAC) Products from the Market

On April 1, 2020 the FDA requested manufacturers of all ranitidine drugs immediately remove their products from the market. The FDA warned that new studies confirm that the levels of NDMA (a known carcinogen) in ranitidine increase over time and when stored at higher temperatures. As a result, ranitidine will no longer be available for existing or over-the-counter use in the United States.

 What You Need to Know

The FDA has learned that some ranitidine medicines, including Zantac, contain unacceptable levels of N-nirtosodimethylamine (NDMA).

People exposed to NDMA may be at an increased risk for digestive tract cancers.

The FDA is advising consumers taking over-the-counter ranitidine to immediately stop using the drug. Prescription users are encouraged to speak with their health care professional about other options.

How Can We Help

If you used heartburn medications and have been diagnosed with a form of digestive tract cancer, you may have a legal claim. If you would like more information about your legal options or would like to talk with a lawyer experienced in this litigation, please give us a call at 1.800.887.8029 or fill out our free case review form on the right side of this page.  All consultations are free and confidential.

Background

Ranitidine, which is more commonly known as Zantac, is a medication that is available in over-the-counter and prescription form. Over-the-counter Ranitidine is approved to prevent and relieve heartburn. Prescription Ranitidine is approved to treat and prevent ulcers of the stomach and intestines. On September 13, 2019 the FDA announced that some ranitidine medicines may contain the impurity NDMA, which is classified as a probable human carcinogen. On April 12020, after new studies confirmed increased risk to public health, the FDA requested manufacturers immediately withdraw all prescription and over-the-counter ranitidine products from the market. 

Reports indicate that individuals who consume unacceptable amounts of NDMA may be at risk of being diagnosed with the following cancers:

  • Stomach Cancer
  • Small Intestine Cancer
  • Colorectal Cancer
  • Esophgeal Cancer
  • Liver Cancer
  • Prostate Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma

Following the FDA’s initial announcement, several ranitidine products were recalled, including some products that tested positive for NDMA.  Below is summary of events following the FDA’s initial announcement:

  • September 13, 2019 – The FDA released a statement alerting patients and health care professionals of NDMA found in samples of ranitidine.
  • September 24, 2019 – Sandoz Inc., voluntarily recalled 14 lots of prescription ranitidine capsules after confirming the presence of NDMA.
  • September 25, 2019 – Apotex Corp, which manufactures ranitidine labeled by Walgreens, Walmart and Rite-Aid, voluntarily recalled all 75mg and 150mg over-the-counter ranitidine tablets.
  • September 28, 2019 – October 2, 2019 Walgreens, CVS, Walmart, and Kroger all announced they were stopping the sale of Zantac and all generic versions of ranitidine.
  • October 2, 2019 – FDA confirmed that, “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”
  • April 1, 2020– FDA requests immediate removal of all ranitidine drugs from the market after studies show increased risk to public health. 

In the News

September 30, 2019: Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears, nytimes.com

October 2, 2019: FDA now says impurity level in Zantac and other antacids is too high, fiercepharma.com

October 2, 2019: Walmart suspends sale of Zantac, other products containing ranitidine over cancer risk, foxbusiness.com

Talk To A Lawyer

If you or a family member was diagnosed with cancer while taking Zantac or any medication containing ranitidine, you may be entitled to compensation.  Complete a free case review form on the right side of this webpage or call 1.800.887.8029 for a free and confidential conversation.

Other FDA Notes

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.  

To report an issue to the FDA, click here.