Cetirizine Hydrochloride Tablets USP 5 mg, 100-count… was recalled on June 24, 2026 in cooperation with the U.S. Food and Drug Administration because cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine…
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Units affected: 34,020 100-count bottles.
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
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.
Class I is the most serious FDA recall level: using or being exposed to the product could cause serious health problems or death.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: JB Chemicals and Pharmaceuticals Ltd
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Undeclared soy allergen: soybean oil and soy lecithin
Undeclared soy allergen: soybean oil and soy lecithin
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