Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., has recalled four lots of Cetirizine Hydrochloride Tablets USP 5 mg nationwide after the tablets were found to be cross-contaminated with ranitidine — a heartburn medication that should not be present in an antihistamine. The recall was announced July 18, 2026, and published by the FDA on July 20, 2026. The contamination was discovered when a pharmacy technician noticed red-colored dots on the tablets while counting them for dispensing. No adverse events have been reported. The tablets were distributed nationwide by Rising Pharma Holdings Inc.
What’s Being Recalled?
Four lots of Cetirizine Hydrochloride Tablets USP 5 mg are included, all packaged in 100-count HDPE bottles with NDC 16571-401-10, an expiration date of October 2028, and distributed by Rising Pharma Holdings Inc. The four affected lot numbers are GY825029, GY825030, GY825031, and GY825032 — printed on the bottle label. No other cetirizine products or lot numbers from Rising Pharma are included in this recall. The product is a generic antihistamine used to treat allergy symptoms including sneezing, runny nose, and itchy eyes.
Why Was This Product Recalled?
Cross-contamination with ranitidine — formerly sold under the brand name Zantac and used to treat heartburn and acid reflux — was discovered after a pharmacy technician flagged the tablets’ unusual appearance during dispensing. Some tablets showed red-colored dots inconsistent with standard cetirizine tablets. For most patients, ranitidine cross-contamination may produce no noticeable effect. However, for consumers with a known hypersensitivity or allergy to ranitidine, ingesting the contaminated cetirizine tablets could trigger severe allergic reactions including hives, facial swelling, throat swelling, difficulty swallowing, difficulty breathing, hypotension, and anaphylaxis — all of which are life-threatening without immediate medical treatment.
What Should You Do?
Check your cetirizine 5 mg bottle for NDC 16571-401-10 and lot numbers GY825029, GY825030, GY825031, or GY825032. If your bottle matches, stop taking the medication and contact your pharmacist for a replacement from an unaffected lot. Contact Rising Pharma Holdings Inc. at 1-844-874-7464, Monday through Friday, 8 a.m. to 5 p.m. ET, or email [email protected] with questions. If you have experienced any adverse symptoms after taking this product, contact your healthcare provider and report the reaction to FDA MedWatch at 1-800-332-1088.
