Antihistamine Recall: 34,000 Bottles at Highest Risk Level
The FDA assigned a rare Class I risk to allergy medication distributed nationwide for unusual cross-contamination. The post Antihistamine Recall: 34,000 Bottles at Highest Risk Level appeared first on The Healthy.
It’s not the first recall we’ve seen for antihistamine, but it might be one of the first with such an elevated alert status. The U.S. Food and Drug Administration (FDA) reserves its top risk level for situations “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the definitions listed on FDA.gov.
A report out Tuesday states that the affected antihistamine was manufactured by an India operation for JB Chemicals and Pharmaceuticals Ltd. The product is 100-count bottles of five-milligram (5 mg) cetirizine hydrochloride tablets—a generic for brands like Zyrtec, though it appears Zyrtec is not affected by this recall.
Identifying recall details
The maker voluntarily initiated the nationwide recall on June 24, with 34,200 bottles affected. October 2028 was the expiration date marked on labels of the following four lot numbers: GY825029, GY825030, GY825031, GY825032.
The Class I update comes this week after the FDA reported the issue triggering the event as, “Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.”
The FDA has described ranitidine as an “important acid-reducing medication” that is “widely used to treat conditions including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.” Commonly known by the brand name Zantac, ranitidine was initially removed from the U.S. market in April 2020 due to presence of an ingredient that the agency called “a probable human carcinogen,” meaning it causes cancer.
However, a “reformulated” version was approved by the agency in November 2025, following “extensive safety testing and manufacturing improvements.”
In either case, drug manufacturer quality control standards would not permit cross-contamination during production or packaging. This appears to be why the the FDA has determined that the risk of drug interaction for users, perhaps especially for an over-the-counter, lower-risk drug like this antihistamine, is significant.
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