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FDA Requests Removal of Ranitidine (Zantac) from Shelves, Advises Users to Stop Taking Drug Immediately

In late 2019, the Food and Drug Administration (FDA) started to investigate Zantac for possibly containing dangerous levels of nitrosodimethylamine (NDMA), an impurity that’s linked to causing cancer. Zantac, sold as ranitidine in its generic form, is a drug that’s primarily used to treat heartburn. It’s sold over the counter as well as in prescription varieties.  

Last year, the FDA recalled sartan blood pressure medications for unsafe levels of NDMA. The agency received criticism for failing to do the same with ranitidine products, especially after many other governments pulled the product from shelves globally. In fact, the United Kingdom’s equivalent to the FDA initiated a recall of the medicine just as the FDA began to acknowledge possible issues with it. While officials from the FDA confirmed it was concerned about NDMA levels in ranitidine, it was hesitant to initiate an official recall due to a pending investigation. However, the FDA’s reluctance didn’t stop many major drug retailers from pulling the product from their shelves.  

Now, the FDA has officially requested the removal of all ranitidine products from shelves nationwide.  

What the FDA Has Found About NDMA Levels in Ranitidine 

In an official press release, the FDA has confirmed that it has found concerning amounts of NDMA in ranitidine products during its ongoing investigation. It determined that impurity in the drug causes consumers to be exposed to an unacceptable level of impurities.  

Notably, the FDA’s investigation has found that some ranitidine products exhibit elevated levels of NDMA as they age, even under normal storage conditions. It also noted that NDMA levels increase if ranitidine products are stored above room temperature. In other words, the drug can develop unsafe levels of impurity during the regular distribution and storage process. This means that these ranitidine products can become more dangerous the older they are and that new products can already begin developing unacceptable NDMA levels before they reach consumers. 

What Should You Do If You Take Zantac or Other Ranitidine Products? 

While this is not an official recall, it comes just short of being one. The FDA is still investigating concerns over ranitidine. However, these findings fall in line with alarms experts around the world sounded months ago. Anyone who is taking this drug should stop immediately, and all stores should remove ranitidine products from their shelves.  

Cancers associated with ranitidine include the following: 

  • Liver cancer 
  • Colorectal cancer 
  • Small intestine cancer 
  • Esophageal cancer 
  • Pancreatic cancer 
  • Gall bladder cancer 
  • Kidney cancer 

If you’ve developed cancer while taking Zantac or any other ranitidine product, you should call Arnold & Itkin LLP as soon as possible. Our Zantac lawsuit lawyers are already representing thousands of individuals across the nation who’ve developed cancer while taking this medication. We know what it takes to obtain results on behalf of clients suffering because of defective and dangerous drugs. In fact, we’ve recently won an $8 billion verdict from Johnson & Johnson. Our team is never intimidated by drug companies. 

Call our Zantac and ranitidine injury lawyers right now at (888) 493-1629. Speaking with a member of our team is free of charge. Most importantly, we never collect a fee unless we earn results for you. 


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