Federal regulators have announced the recall of specific lots of Cetirizine hydrochloride Tablets, commonly sold over the counter as generic versions of Zyrtec, due to concerns of cross-contamination with ranitidine.
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., initiated the voluntary recall on Saturday. The affected tablets may contain ranitidine, a medication previously used for stomach acid production that was removed from the U.S. market in 2020 due to concerns over a probable human carcinogen. A reformulated version of ranitidine was approved in 2025.
The U.S. Food and Drug Administration (FDA) warned that consumers with a hypersensitivity to ranitidine could experience serious adverse events, including anaphylaxis, a rapid and potentially life-threatening allergic reaction. Symptoms of anaphylaxis can include low blood pressure, difficulty breathing, swallowing difficulties, throat or facial swelling, intense itching, hives, and loss of consciousness.
Unique Pharmaceuticals stated it has not received any reports of adverse events linked to this recall. The issue was reportedly discovered when a pharmacy technician observed discrepancies while counting tablets, noting some had a “red dot” or appeared discolored.
The recalled products were distributed nationwide to wholesalers and retailers. The affected antihistamine is packaged in 100-count bottles of 5 mg cetirizine hydrochloride tablets USP under the National Drug Code (NDC) 16571-401-10. The four manufacturing lots included in the recall are GY825029, GY825030, GY825031, and GY825032. All affected lots have an expiration date of October 2028.
Unique Pharmaceuticals has informed its distributor, Rising Pharma Holdings Inc., about the recall. Consumers with questions can contact Rising Pharma Holdings Inc. at 1-844-874-7464 between 8 a.m. and 5 p.m. ET, Monday through Friday, or by emailing [email protected].