A nationwide cetirizine recall covers four lots of 5 mg allergy tablets distributed by Rising Pharma after red dots and discoloration suggested possible ranitidine contamination. Consumers should check lot numbers, watch for severe allergic reactions and report problems.
Unique Pharmaceutical Laboratories has voluntarily recalled four lots of Cetirizine Hydrochloride Tablets USP 5 mg at the consumer level because of potential cross-contamination with ranitidine.
The company announced the nationwide recall on Saturday, July 18, 2026, and the U.S. Food and Drug Administration published the notice on Monday, July 20, 2026.
Why the Cetirizine Tablets Were Recalled
The issue was reported after a pharmacy technician noticed red dots and discoloration on some tablets while preparing a prescription.
The antihistamine was packaged in high-density polyethylene bottles containing 100 tablets under NDC 16571-401-10. Rising Pharma Holdings Inc. distributed the affected product nationwide to wholesalers and retailers.
Recalled Cetirizine Lot Numbers
Consumers should check their bottles for the following lot numbers:
GY825029, GY825030, GY825031 and GY825032.
All four recalled lots have an expiration date of October 2028. The lot number, product name and manufacturer information can be found on the bottle label.
Possible Ranitidine Allergy Risk
The recall notice said people who are hypersensitive to ranitidine ingredients could experience a serious reaction after taking a contaminated tablet.
Possible symptoms include anaphylaxis, low blood pressure, breathing or swallowing difficulty, swelling of the face or throat, hives, severe itching and loss of consciousness. No adverse events connected to the recall had been reported as of the FDA notice.
What Consumers Should Do
Rising Pharma is notifying distributors and direct customers and arranging for recalled products to be returned.
Consumers with questions may call 1-844-874-7464 from 8:00 AM to 5:00 PM Eastern Time, Monday through Friday. Questions may also be emailed to Email [email protected] or [email protected].
Anyone experiencing symptoms or another suspected medication-related problem should contact a healthcare professional. Adverse reactions and product-quality complaints may also be submitted through the FDA’s MedWatch safety reporting program.
