FDA Requests Zantac and other Ranitidine Medications be Pulled from Shelves

April 24, 2020
by We can Help Law

The medication ranitidine that is widely known as Zantac has been removed from shelves in many different locations.  Zantac is a heartburn and ulcer medication.  The removal of all ranitidine products was initiated by the Food and Drug Administration (FDA).  The FDA stated that they are issuing the removal and recall because they have come to the determination that the medication can become impure after the medication is stored at higher room temperatures.


The FDA specifically requested that the manufacturers and distributors of ranitidine products withdraw them from the market.  The FDA further advised that consumers who have the products in their homes should dispose of them and not buy any further doses.  Finally the FDA advised that consumers should seek other treatment as appropriate.


Even before the announcement from the FDA, several pharmaceutical companies began to withdraw their products. Additionally, CVS and Walgreens pulled the products from their shelves.


What is the Reason for the Recall?

The reason these drugs have been recalled is because a small amount of NDMA was detected in the products.  NDMA is a cancer-causing substance. NDMA is a substance that is routinely found in water and other food that humans consume but it is thought to be at such a low level in these foods, that it is not harmful.  However, the substance is classified as a known human carcinogen when an individual is exposed to a larger amount of NDMA.  NDMA is specifically thought to cause gastric or colorectal cancer according to various sources.  The substance is also thought to be toxic to the liver and may cause liver damage.

NDMA is a byproduct of some industrial and manufacturing processes.  These manufacturing processes can include the manufacturing of rubber products.


Colorectal Cancer

Colorectal cancer is cancer of the colon and rectal.  Cancer in this area generally starts with polyps that can eventually grow into cancer.  This growth typically takes many years.  There are two types of polyps according to the American Cancer Society.  Adenomatous polyps (adenomas): These polyps sometimes change into cancer. Because of this, adenomas are called a pre-cancerous condition.  Hyperplastic polyps and inflammatory polyps: These polyps are more common, but in general they are not pre-cancerous.  Some other factors that can increase the risk of cancer can include, larger polyps or multiple polyps found in an area.  Colorectal cancer can spread throughout the body if it continues to grow and is not detected early.


Claims regarding Ranitidine Medications

If you or someone you know have suffered an injury, including a cancer diagnosis, as a result of using a medication containing ranitidine, you may be able to file a claim as a result of the diagnosis.  There are various claims which may be filed against the manufacturer or distributor of the ranitidine medication.  Some of those claims include:


Failure to Warn

A failure to warn claim is a claim that is advanced against the manufacturer and or distributor of a product that alleges that the manufacturer or distributor failed to warn the public against a potential side effect or complication.  If the plaintiff is successful in proving a failure to warn claim, the plaintiff may be entitled to compensation for the injuries that they suffered.  In order to prove a failure to warn claim, the plaintiff will need to establish that the manufacturer or distributor knew about a potential danger or side effect or that the manufacturer or distributor should have known about a potential side effect and thereafter did not issue a warning about the safety concern or side effect.  Another form of a failure to warn claim can include a claim that the manufacturer or distributor knew or should have known about a safety concern or side effect, did issue a warning, but that warning was not adequate in order to advise the public of the dangers that are associated with the product.


Product Liability Claim

A product liability claim is a claim that is advanced against the manufacturer or distributor of a product alleging that the product was defective or unfit for its intended use.  This type of claim can be brought against the manufacturer or distributor of a product that is used in the home or workplace, but it can also be brought in regard to a medical or pharmaceutical product.  Similar to any other personal injury claims, if the plaintiff proves that the manufacturer or distributor of a product caused the injury, they will be responsible for the harm caused.



If you or someone you know has suffered an injury as a result of ingesting a product containing ranitidine, call our law firm day or night.  Our attorneys will take the time to discuss all of your potential options.  We offer a free consultation in regard to all personal injury matters.  Additionally, our firm will only receive a legal fee if we win your case.