FDA RECALL: Cetirizine Hydrochloride Tablets USP 5 mg

Four Lots Recalled for Ranitidine Cross‑Contamination

FDA Recall: issued for four lots of Cetirizine Hydrochloride Tablets USP 5 mg, an over‑the‑counter (OTC) antihistamine, after testing confirmed cross‑contamination with ranitidine. The recall, initiated by Unique Pharmaceutical Laboratories, is classified at the consumer level.

The affected product consists of 100‑count HDPE bottles (NDC 16571‑401‑10) with October 2028 expiration dates. A pharmacy technician first reported red dots and tablet discoloration, prompting investigation and confirmation of ranitidine presence.

This product was distributed nationwide, it is likely to have reached pharmacies and retailers in Brunswick County, NC and Horry County, SC.  Residents who purchased store‑brand or generic cetirizine should check their bottles for the affected lot numbers.

Recalled Lots – GY825029, GY825030, GY825031 and Lot# GY825032

Individuals with ranitidine hypersensitivity may experience severe allergic reactions, including anaphylaxis, hypotension, shortness of breath, facial or throat swelling, hives, or loss of consciousness.

The FDA advises consumers to take the following steps:

Stop using the product immediately and check the lot number on the bottle. No return is required to receive a refund.

Dispose of the tablets safely at home by mixing them with an undesirable substance (such as coffee grounds or cat litter), sealing them in a plastic bag, and placing the bag in household trash.

Contact the manufacturer for refund processing or questions, 775.451.6171 and by email: info@zenprinciple.com