Zantac Recall: FDA Recalls All Zantac & Ranitidine Products

Posted on 04/01/2020Back

On April 1, 2020, The Food and Drug Administration (FDA) requested the recall of all Zantac and ranitidine products from the U.S. market due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA).

Do I Have A Case?

Why Is The FDA Recalling All Zantac Products?

The FDA Zantac recall announcement acknowledges that NDMA impurities in the popular heartburn medications can increase to dangerous levels when the products are stored over time or exposed to higher temperatures. This determination echoes the findings reported to the FDA earlier this year by Emery Pharma, which found steady increases of NDMA production in Zantac and ranitidine products stored just above room temperature. Emery’s study also produced levels of NDMA exceeding the FDA’s daily acceptable intake limit of 96 nanograms in ranitidine products stored in temperatures as low as 158 degrees Fahrenheit for as little as five days.

Emery submitted these findings to the FDA in a Citizen Petition on January 2, 2020 and recommended the agency recall all Zantac and ranitidine products from the market. Additional testing has since found that older ranitidine products contained greater levels of NDMA, suggesting that NDMA levels in the drugs can increase over time.

Is This The First Zantac Recall?

No. The FDA has announced 16 different recalls of Zantac and ranitidine products since tests began discovering NDMA in the heartburn medications in September 2019. Until now, the agency had refrained from withdrawing all Zantac and ranitidine products from the market due to inconsistencies in NDMA levels found in previous tests. However, the FDA has now concluded that it can no longer guarantee the safety of the products due to unknowns about duration and conditions in which the drugs have been stored.

What Should I Do If I Am Currently Taking Zantac?

The FDA is recommending users of over-the-counter Zantac and ranitidine products to cease use immediately and safely dispose of any remaining medication. The agency advises patients taking prescription ranitidine products to speak with their healthcare provider to discuss alternative treatment options.

What Is NDMA and Why Is It Dangerous?

NDMA is considered a probable human carcinogen by multiple global health organizations. It was previously used to make rocket fuel, however, this was stopped after unusually high levels of the compound were found in the air, water, and soil samples collected near a rocket fuel manufacturing plant. NDMA is now only intentionally produced in the U.S. for research purposes.

Human exposure to unsafe levels of NDMA in Zantac and ranitidine products has been linked to the following cancers:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal / Intestinal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Prostate Cancer

How We Can Help

GoldenbergLaw is currently representing clients who have been diagnosed with cancer after taking Zantac or ranitidine products. The Zantac Recall Attorneys at GoldenbergLaw have over 30 years of experience delivering justice to victims of corporate negligence. If you are interested in learning more about a Zantac recall lawsuit, contact us today for a free consultation. Let us delivery the Gold standard advocacy you deserve.

Category Dangerous Drugs News Safety Information