Unique Pharmaceutical Laboratories has initiated a voluntary nationwide recall of four lots of Cetirizine Hydrochloride Tablets USP 5 mg due to potential cross-contamination with ranitidine. This recall, announced on July 18, 2026, addresses a significant health risk for consumers.
The presence of ranitidine poses a reasonable probability of serious adverse events for individuals with hypersensitivity to its ingredients. Such reactions could include severe hypersensitivity and anaphylaxis, manifesting as hypotension, dyspnea, difficulty swallowing, and facial edema, which are potentially life-threatening conditions.
Despite the serious nature of the potential risks, Unique Pharmaceutical Laboratories, based in Panoli, Gujarat, has not received any reports of adverse events related to this specific recall to date. The recall is being conducted to the consumer level to ensure public safety.