Unique Pharmaceutical Laboratories has issued a voluntary, nationwide recall for four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, following reports of cross-contamination with Ranitidine.

The affected medication is distributed nationwide by Rising Pharma Holdings Inc. in 100-count HDPE bottles (NDC: 16571-401-10). The issue was first identified by a pharmacy technician who noticed discolored tablets featuring multiple red dots during dispensing.

Key Recall Details

• Product: Cetirizine Hydrochloride Tablets USP 5 mg (100-count bottles)

• Manufacturer: Unique Pharmaceutical Laboratories

• Distributor: Rising Pharma Holdings Inc.

• Expiration Date: 10/2028

• Affected Lot Numbers:

  • GY825029

  • GY825030

  • GY825031

  • GY825032

Health Risks & Safety Information

While no adverse events have been reported to date, consuming tablets contaminated with ranitidine poses a severe risk to individuals with ranitidine hypersensitivity. Potential adverse events include life-threatening allergic reactions, facial and throat edema, severe difficulty breathing, severe drop in blood pressure (hypotension), rashes, and loss of consciousness.

What to do: Consumers should inspect their medication bottles for the impacted lot numbers and contact their physician or healthcare provider immediately if they experience any health issues related to this product.

Contact & Reporting

Rising Pharma Holdings Inc. is notifying distributors and customers to arrange product returns. For general or medical inquiries regarding this recall, consumers can contact Rising Pharma through the following channels:

• Phone: 1-844-874-7464 (Monday–Friday, 8:00 a.m. – 5:00 p.m. EST)

• Email: [email protected] or [email protected]

Adverse reactions or quality issues may also be reported directly to the FDA’s MedWatch Adverse Event Reporting Program online or by phone at 1-800-332-1088. This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.