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.
Prior to the FDA market withdrawal request, Apotex, Sandoz (Novartis), and GlaxoSmithKline (GSK) recalled generic Zantac sold at Rite Aid, Walgreens, and Walmart. Some versions of generic Zantac (ranitidine hcl) were also recalled in Canada and Europe.
The following is a complete list of the companies that issued Zantac (ranitidine) recalls before the FDA “market withdrawal” announcement:
American Health Packaging
Aurobindo Pharma USA
Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg,
labeled by Walgreens, Walmart, and Rite-Aid)
Denton Pharma (dba Northwind Pharmaceuticals)
Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines
labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
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. Three months later, the company filed a citizen’s petition urging 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.”
On Jan. 2, 2020, research laboratory Emery Pharma filed a citizen’s petition of its own noting that ranitidine is a time and temperature-sensitive pharmaceutical product that develops into NDMA when exposed to heat. In a press release, Emery Pharma noted:
“Exposure to high temperatures is a common occurrence during transportation and storage, and is of specific concern to ranitidine as there currently are no requirements for the drug to be shipped in temperature-controlled conditions and/or stored under refrigeration.”
Did the FDA Issue a Zantac Recall in 2019?
Despite evidence that Zantac can cause cancer, the U.S. Food and Drug Administration (FDA) did not immediately issue a Zantac recall in 2019. The agency warned 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.
While the FDA was reluctant to issue a Zantac recall in 2019, retail outlets like Walgreens, Walmart, Rite Aid, CVS and others pulled the popular medication from shelves. Generic drug makers like Sandoz (a division of Novartis), GSK, and Apotex also issued generic Zantac recalls in 2019; and nearly two dozen countries stopped or restricted sales of the popular medication.
In April of 2020, the FDA issued a market withdrawal for Zantac, which is not the same thing as a recall. Per the FDA, here is the difference between a recall and a market withdrawal:
Market withdrawal: Involves a minor violation that would not be subject to legal action by the FDA.
Recall: The correction or removal of a marketed product that the FDA considers to be in violation of the laws it administers.
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
The Zantac cancer lawyers at Baum, Hedlund, Aristei & Goldman believe the FDA’s decision to issue a market withdrawal for Zantac is a necessary step toward protecting people from a dangerous drug. However, more can and should be done. Our firm has been calling for a Zantac recall since the summer of 2019 because there is no level of NDMA that is safe.
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.