FDA Elevated Cetirizine Recall to Class I: The agency upgraded a voluntary nationwide recall after lab tests found ranitidine contamination in 100-count, 5 mg cetirizine tablets. A total of 34,200 bottles from four lots (GY825029–GY825032) with an October 2028 expiration are affected. Consumers should stop using affected bottles and follow manufacturer or FDA guidance.
FDA Escalates Antihistamine Recall to Class I After Ranitidine Contamination — 34,200 Bottles Affected
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The U.S. Food and Drug Administration has upgraded a nationwide recall of cetirizine (generic Zyrtec) tablets to a Class I recall — the agency’s highest risk level — after laboratory testing found ranitidine contamination in the product.
Details of the Recall
The recall, voluntarily initiated by the manufacturer on June 24, affects 34,200 bottles of 100-count, 5 mg cetirizine hydrochloride tablets manufactured at a facility in India for JB Chemicals and Pharmaceuticals Ltd. The affected lot numbers are GY825029, GY825030, GY825031 and GY825032, and the labels show an expiration date of October 2028. Branded Zyrtec does not appear to be part of this recall.
What Triggered the Upgrade to Class I
The FDA reported that consumer complaints described discolored tablets and red dots. Laboratory analysis determined the contaminant to be ranitidine. The agency reserves a Class I designation 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.”
About Ranitidine
Ranitidine — widely known by the brand name Zantac — is an acid-reducing medicine used to treat conditions such as GERD and peptic ulcers. It was removed from the U.S. market in April 2020 after an impurity was classified by the FDA as a “probable human carcinogen.” A reformulated ranitidine product was later approved by the FDA in November 2025 following additional safety testing and manufacturing improvements.
Why This Is Concerning
Regardless of ranitidine’s regulatory history, cross-contamination of an over-the-counter antihistamine with another active pharmaceutical ingredient represents a significant manufacturing lapse. The presence of ranitidine in cetirizine tablets raises concerns about potential adverse reactions and drug interactions, which is why the FDA upgraded the recall to Class I.
What Consumers Should Do
- Stop using any affected bottles immediately.
- Check your bottle for the lot numbers GY825029–GY825032 and the October 2028 expiration date.
- Follow recall instructions from the manufacturer or contact the FDA for guidance on returns, refunds or disposal.
- If you experience unexpected symptoms after taking the product, contact your healthcare provider promptly.
For official recall details and updates, refer to the FDA recall notice and the manufacturer’s recall communication.
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