Unique Pharmaceutical Laboratories is pulling 4 lots of cetirizine hydrochloride tablets that may contain ranitidine, which can trigger severe allergic reactions
Credit: Cetirizine Hydrochloride Tablets USP 5 mg / Rising Pharma Holdings Inc.
Unique Pharmaceutical Laboratories issued a voluntary nationwide recall of four lots of cetirizine hydrochloride tablets USP 5 mg — a generic form of the allergy medication Zyrtec — over possible cross-contamination with ranitidine, a heartburn drug. The recall was announced July 18.
The company, a division of J.B. Chemicals & Pharmaceuticals Ltd. based in Panoli, Gujarat, India, said the tablets reached customers across the country via wholesale and retail channels. Distributor Rising Pharma Holdings Inc. has notified customers by email and is arranging returns of affected product, according to the FDA.
The four recalled lots — GY825029, GY825030, GY825031, and GY825032 — are packaged in 100-tablet high-density polyethylene bottles under NDC 16571-401-10, with an expiration date of October 2028. The FDA said the issue was uncovered when a pharmacy technician spotted unusual markings — including red dots and discolored tablets — while filling a prescription.
Ranitidine, marketed under the brand name Zantac, was pulled from U.S. shelves in 2020 when regulators determined it was tainted with a substance classified as a probable human carcinogen, according to Fox Business. The drug was permitted back on the market after a reformulated version won FDA approval in 2025, according to The Hill.
The FDA said that for people with a sensitivity to ranitidine ingredients, ingesting the contaminated cetirizine tablets carries a risk of serious adverse events, including anaphylaxis. According to the FDA, a reaction could present as hives, facial or throat swelling, a drop in blood pressure, breathing difficulties, problems swallowing, or a loss of consciousness. Unique Pharmaceutical Laboratories said it has not received any reports of adverse events tied to the recall.
Rising Pharma Holdings Inc. is available to field consumer questions at 1-844-874-7464 between 8 a.m. and 5 p.m. ET, Monday through Friday, or by email at [email protected] or [email protected]. Anyone who has experienced a problem related to the product should contact a physician or healthcare provider. Adverse reactions can also be reported to the FDA's MedWatch program online or by calling 1-800-332-1088.
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