ZANTAC RECALL UPDATE: On April 1, 2020, the FDA announced that manufacturers are to withdraw all Zantac and generic Zantac medications from the market effective immediately. In the scope of its investigation into Zantac, FDA determined that N-Nitrosodimethylamine (NDMA) in some Zantac drugs “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…” The Environmental Protection Agency (EPA), the World Health Organization (WHO), and the FDA all classify NDMA as a carcinogen.
Which Zantac Has Been Recalled?
According to the news media, three drug manufacturers—Apotex, Sandoz (Novartis), and GlaxoSmithKline (GSK)—have recalled generic Zantac sold at Rite Aid, Walgreens, and Walmart. Some versions of generic Zantac (ranitidine hcl) have been recalled in Canada and Europe.
The following companies have issued Zantac (ranitidine) recalls (updated January of 2020):
Denton Pharma (dba Northwind Pharmaceuticals)
Golden State Medical Supply
American Health Packaging
Aurobindo Pharma USA
Dr. Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
The U.S. Food and Drug Administration (FDA) is warning consumers that testing of the popular heartburn medication Zantac (generic ranitidine) revealed a known cancer-causing chemical, N-nitrosodimethylamine (NDMA) at more than 3,000 times the legal daily intake limit. In a statement issued in October of 2019, the FDA noted, “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”
While the FDA is investigating the cancer link, the agency has not yet issued a formal Zantac recall 2019 notice. Despite the FDA’s reluctance to issue a recall for Zantac, retail outlets like Walgreens, Walmart, Rite Aid, CVS and others are pulling the popular medication from shelves; generic drug makers like Sandoz (a division of Novartis), GSK, and Apotex have issued generic Zantac recalls; and nearly two dozen countries have taken action to stop or restrict sales of the popular medication.
What is the Problem with Zantac?
Connecticut-based online pharmacy Valisure tests medications for consistency and quality issues. During testing, the company discovered extremely high levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”
NDMA is a chemical that the FDA, Environmental Protection Agency (EPA), and World Health Organization (WHO) all classify as a substance capable of causing cancer.
Valisure’s finding was consistent with studies from Stanford University and elsewhere, which found that NDMA in Zantac was likely due to the “inherent instability” of the ranitidine molecule.
“There’s no acceptable cancer risk for a drug like this,” said David Light, CEO of Valisure.
Valisure reported its findings to the FDA in June of 2019, and three months later, the company petitioned the FDA to issue a Zantac recall and suspend all sales:
“Combined with other data from Valisure and the scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen.”
2018 Valsartan NDMA Recall
In 2018, some companies issued recalls after the discovery of high levels of NDMA in multiple generic forms of the blood pressure drug valsartan. The levels of NDMA in these products, however, paled in comparison to that of Zantac.
The 2018 recalls were reportedly linked to NDMA that formed during manufacturing after active ingredient suppliers in India and China sold components of the medication to generic drug makers. Government officials have not commented on how NDMA ended up in the drugs.
Zantac Cancer Lawyers Call for FDA Ranitidine Recall
While the FDA investigation into this serious public health issue is a necessary step, the Zantac cancer lawyers at Baum, Hedlund, Aristei & Goldman believe the agency is downplaying the true danger of the Zantac cancer risk by claiming the amount of NDMA found during testing is low.
Regulators outside of the United States caution patients against taking Zantac, noting the availability of safer alternatives. The FDA, on the other hand, is dragging its feet on issuing a Zantac recall. Simply put, by telling consumers that they do not need to stop taking Zantac or Zantac OTC generics, the FDA is confusing the American public, not protecting it.
Free Zantac Lawsuit Review
If you or a member of your family took ranitidine (Zantac) and developed cancer, you need an attorney with experience litigating against major drug companies. The Zantac cancer attorneys from the law firm of Baum Hedlund Aristei & Goldman have years of experience holding big corporations accountable for concealing the dangers of consumer products.
Since 1973, our firm has obtained more than $4 billion in verdicts and settlements on behalf of clients across all areas of practice. The firm’s track record of success speaks for itself: we know how to win big cases against big companies.