Allergy medication recalled over possible drug mix-up that could trigger 'life-threatening' reactions - Fox Business

What the report says

Fox Business reported that the U.S. Food and Drug Administration announced a nationwide voluntary recall of some cetirizine hydrochloride tablets, an over-the-counter allergy medicine commonly sold as generic Zyrtec, because of a possible mix-up or cross-contamination with ranitidine. The FDA notice was announced Monday, and the recall was initiated Saturday by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in Panoli, Gujarat, India.

The affected product is cetirizine hydrochloride tablets USP, 5 mg, packaged in 100-count high-density polyethylene bottles under NDC 16571-401-10. The recall covers four lots — GY825029, GY825030, GY825031 and GY825032 — all with an October 2028 expiration date. Fox Business, citing regulators, said the products had been distributed nationwide to wholesalers and retailers.

According to the FDA information cited in the report, ranitidine contamination could pose a serious risk to people with hypersensitivity to ingredients in that medication, including possible anaphylaxis. Symptoms of anaphylaxis can include breathing problems, low blood pressure, swelling of the face or throat, hives, severe itching, trouble swallowing and loss of consciousness. Unique Pharmaceuticals said it had not received reports of adverse events linked to the recalled lots.

Regulators said the issue surfaced after a pharmacy technician noticed unusual tablet appearances while counting pills, including discoloration and red dots or spots. Ranitidine, previously sold under the Zantac name, was removed from the U.S. market in 2020 over contamination concerns involving a probable human carcinogen; Fox Business reported that a reformulated version was later approved in 2025. Consumers with questions were directed to Rising Pharma Holdings at 1-844-874-7464 or pv@risingpharma.com.