We believe the medications we take, whether they be prescription or over-the-counter (OTC), are safe and effective. However, dangerous drugs occasionally receive regulatory approval and end up in consumers’ hands. Zantac (ranitidine) is one such drug.
A popular OTC heartburn medication, Zantac was removed from store shelves in 2020 following a market withdrawal request from the U.S. Food and Drug Administration (FDA). While it was the manufacturers who actually recalled the drug, the reason for this recall is alarming and something that no consumer ever wants to hear—Zantac contains a known carcinogen at dangerously high levels.
Learn more about the Zantac recall and what you can do if you have been harmed by this dangerous drug.
Why Was There a Recall for Zantac?
Ranitidine, known by the brand name Zantac, is a prescription and OTC drug that functions as a histamine H2-receptor antagonist (or H2 blocker). H2 blockers bind to stomach cells that produce acid to neutralize acid secretion. Ranitidine prevents and treats heartburn, acid reflux, and a host of other digestive issues.
A 2019 investigation by Valisure, an independent quality assurance pharmacy, revealed that the ranitidine molecule contains a dangerous carcinogen known as N-Nitrosodimethylamine (NDMA) at “unacceptable levels,” according to the FDA. When ranitidine medications are stored over long periods of time at higher than normal room temperatures, consumers may be exposed to even higher levels of NDMA.
According to the World Health Organization (WHO) and the U.S. Environmental Protection Agency (EPA), NDMA is a probable human carcinogen, which means it may cause cancer. While many people consume low levels of NDMA through food and water, higher levels of NMDA may increase the risk of cancer.
How Does a Drug Recall Work?
A recall is initiated when a medication is found to be defective, potentially harmful, or both. In the case of Zantac, the FDA issued a “market withdrawal request” in response to scientists discovering exceedingly high levels of NDMA in ranitidine medications.
Drug manufacturers or the FDA can issue recalls. If a drug company discovers a potential health hazard, manufacturing issue, or defect, it can issue a voluntary recall. If the FDA receives requests for a recall after the public discovers safety problems with a medication, the agency can issue a recall or the removal of the medication from the market
The FDA’s role in a drug recall involves classifying the severity of the product’s danger so the public can understand why the recall is happening. The three classifications of recalls include the following:
- Class I: A dangerous or defective product that could cause serious health problems or death.
- Class II: A product that might cause a temporary health problem or pose a slight threat of a serious nature.
- Class III: A product that is unlikely to cause any adverse health reaction but violates FDA labeling or manufacturing laws.
What is the Difference Between a Market Withdrawal and a Recall?
Here is the difference between a market withdrawal and a recall:
A market withdrawal is initiated when FDA finds a “minor violation” that would not be subject to legal action by the agency.
A recall is initiated when FDA considers a marketed product to be in violation of the laws it administers and subject to legal action (including seizure, for example).
The FDA decided it did not have enough information to issue a recall; thus, prompting a market withdrawal. Based on the unacceptable levels of NDMA in ranitidine medications as reported in the Valisure and Emery Pharma Citizen Petitions to the FDA, we find it concerning that the FDA didn’t actually issue a recall. Rather, the FDA requested that all manufacturers withdraw their Zantac and ranitidine products off the market.
In the end, it was the drug manufacturers that recalled their own Zantac and ranitidine products.
When Was Zantac Recalled?
The FDA issued its market withdrawal request of Zantac and other ranitidine drugs on April 1, 2020, the day the agency announced its findings that the levels of NDMA in these drugs could increase “over time and when stored at higher than room temperatures.” The FDA’s request to remove all ranitidine products from the market was effective immediately—all ranitidine drugs were made unavailable for new and existing prescriptions and OTC use alike.
Drug companies began issuing Zantac recalls in September of 2019, weeks after Valisure filed its Citizen Petition to the FDA.
If you have been to your local pharmacy, you may be surprised to see Zantac back on the shelves. The makers of Zantac rebranded the drug after it was pulled from shelves last year. The new Zantac medication, Zantac 360, contains the active ingredient famotidine instead of ranitidine. Famotidine is the generic name for Pepcid. Like ranitidine, famotidine belongs to the class of drugs known as H2 blockers (histamine type-2 receptor antagonists).
Drug Manufacturers’ Responsibility
Under product liability law, drug manufacturers have a legal responsibility to create products that are safe for human use and/or consumption. There are three types of product defects that may incur liability in manufacturers:
- Design defects: Defects that existed before the product was manufactured. The product may be unreasonably dangerous due to an inherent design flaw.
- Manufacturing defects: Defects that occurred during the physical construction or assembly of the product. Often, only a few out of many products of the same type are flawed in this case.
- Marketing defects: A product contained improper instructions and/or failed to warn the consumer of any possible dangers resulting from use of the product.
In the case of Zantac, mounting evidence has shown that the makers of Zantac were aware of and knowingly concealed the NDMA cancer link while raking in record-shattering revenue. Zantac lawsuits allege defective design and failure to warn against the following defendants:
- Boehringer Ingelheim Pharmaceuticals, Inc.
- GlaxoSmithKline LLC
- Pfizer Inc.
- Sanofi US Services Inc.
Harmed by Ranitidine? Contact a Zantac Lawyer Today
We trust that the drugs we purchase and consume will help us, not hurt us. Sadly, however, some drug manufacturers are more concerned with generating profits than keeping consumers safe. If you or a family member developed cancer after using Zantac, our Los Angeles trial attorneys want to fight for you.
Baum Hedlund Aristei & Goldman has 40 years of experience taking on large corporations, including several of the largest drug companies in the world. We have recovered billions of dollars in settlements and verdicts for clients harmed by corporate greed.
Call Baum Hedlund Aristei & Goldman at (855) 948-5098 to schedule a free consultation.