Federal regulators on Monday announced the recall of a popular allergy medication over concerns it may have been cross-contaminated with another drug, potentially causing “life-threatening” reactions.
The U.S. Food and Drug Administration (FDA) said certain lots of Cetirizine hydrochloride Tablets, commonly sold over the counter as generic versions of Zyrtec, are affected by the voluntary recall.
The recall was initiated Saturday by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India, according to the FDA.
The affected tablets may be contaminated with ranitidine, a medication once widely used to reduce stomach acid production. Ranitidine, sold under the brand name Zantac, was removed from the U.S. market in 2020 after regulators raised concerns over contamination with a probable human carcinogen.
A reformulated version of the medication was later approved by regulators in 2025.
The FDA warned that some consumers could experience “serious adverse events,” including anaphylaxis, a rapid and potentially life-threatening allergic reaction.
“For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events,” the FDA said.
Anaphylaxis symptoms may manifest as low blood pressure, difficulty breathing, trouble swallowing, swelling of the throat or face, intense itching, hives and loss of consciousness.
Unique Pharmaceuticals said it has not received any reports of adverse events associated with the recall.
The issue was discovered after a pharmacy technician noticed discrepancies while counting tablets during dispensing, according to regulators.
Some tablets appeared to have a “red dot,” while others appeared discolored or had multiple red-colored spots.
The recalled products were reportedly distributed nationwide to wholesalers and retailers.
The affected antihistamine is packaged in a high-density polyethylene (HDPE) bottle containing 100 tablets of 5 mg cetirizine hydrochloride tablets USP under the National Drug Code (NDC) 16571-401-10.
Four manufacturing lots are included in the recall: GY825029, GY825030, GY825031 and GY825032. All affected lots have an expiration date of October 2028.
Unique Pharmaceuticals has notified its distributor, Rising Pharma Holdings Inc., of the recall.
Consumers with questions about the recall 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].
