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The recall concerns specific lots of Cetirizine hydrochloride Tablets, an over-the-counter antihistamine used to treat allergy symptoms. The FDA said the voluntary recall was initiated by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India.
The agency warned that people with a sensitivity to ranitidine ingredients could face a risk of serious adverse events, including anaphylaxis, a rapid allergic reaction that can become life-threatening.
FDA Lists Four Affected Cetirizine Production Lots
According to the FDA, the recalled medication is Cetirizine hydrochloride Tablets USP packaged in a high-density polyethylene (HDPE) bottle containing 100 tablets of 5 mg cetirizine hydrochloride. The product is identified by National Drug Code (NDC) 16571-401-10.
The recall includes four manufacturing lots: GY825029, GY825030, GY825031 and GY825032. Each affected lot has an expiration date of October 2028.
The FDA said the tablets may have been cross-contaminated with ranitidine, a medication previously used to reduce stomach acid production. Ranitidine was sold under the brand name Zantac and was removed fromthe U.S. market in 2020 after regulators raised concerns about contamination with a probable human carcinogen. A reformulated version of the medication was approved by regulators in 2025.
The recalled cetirizine tablets were distributed nationwide to wholesalers and retailers.
FDA Warns of Possible Serious Allergic Reactions
According to the FDA, consumers with hypersensitivity to ranitidine ingredients may experience serious adverse events after taking cetirizine tablets contaminated with the medication.
The possible symptoms of anaphylaxis include low blood pressure, difficulty breathing, trouble swallowing, swelling of the throat or face, intense itching, hives and loss of consciousness.
The FDA said the contamination concern was discovered after a pharmacy technician noticed differences while counting tablets during dispensing. Some tablets appeared to have a red dot, while others were discolored or showed multiple red-colored spots.
Unique Pharmaceuticals said it has not received any reports of adverse events related to the recall.
Rising Pharma notified as recall affects nationwide distribution
Unique Pharmaceuticals notified its distributor, Rising Pharma Holdings Inc., about the recall. Consumers seeking information about the affected products can contact Rising Pharma Holdings Inc. at 1-844-874-7464 from 8 a.m. to 5 p.m. ET, Monday through Friday, or email [email protected].
According to the FDA, the recall applies to the identified lots of cetirizine tablets and was initiated voluntarily after the possible drug mix-up was found.
The agency advised consumers to check their medication packaging to determine whether their tablets are included in the recall and to contact the distributor with questions.
