Allergy medication recalled over possible mix-up that could cause 'life-threatening' reactions

Allergy medication recall highlights federal concerns that a widely sold antihistamine may have been cross-contaminated with ranitidine, potentially triggering “life-threatening” reactions. On Monday, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of certain lots of Cetirizine hydrochloride Tablets, sold over the counter in generic versions of Zyrtec. The recall began Saturday, initiated by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., located in Panoli, Gujarat, India. Affected tablets may contain ranitidine, which was removed from the U.S. market in 2020 due to contamination concerns involving a probable human carcinogen, although a reformulated version was approved in 2025. The FDA warned some consumers could experience serious adverse events, including anaphylaxis. Unique said it has not received reports of adverse events. Regulators traced the discovery to discrepancies noticed by a pharmacy technician, including tablets with a “red dot” or discoloration. The product was distributed nationwide to wholesalers and retailers, packaged in 100-count HDPE bottles labeled NDC 16571-401-10 for four lots expiring October 2028.