Cetirizine allergy tablets recalled nationwide over Ranitidine contamination risk

The U.S. Food and Drug Administration (FDA) published a nationwide alert confirming that four specific production lots of the popular 5 mg generic antihistamine are being pulled from market shelves and wholesale distributors.

The discrepancy came to light when a vigilant pharmacy technician noticed abnormal red spotting and general discoloration on the white 5 mg tablets while counting doses for a prescription.

Affected Product Identification

Consumers and healthcare providers are urged to inspect their medicine cabinets for 100-count HDPE bottles of Cetirizine Hydrochloride Tablets USP, 5 mg, distributed by Rising Pharma Holdings Inc. and manufactured by Unique Pharmaceutical Laboratories. The affected product carries the National Drug Code (NDC) 16571-401-10 and an expiration date of 10/2028. This recall specifically applies to four lot numbers: GY825029, GY825030, GY825031, and GY825032.

Health Risks Associated with Cross-Contamination

Cetirizine is an over-the-counter and prescription antihistamine commonly used to treat seasonal allergies, hives, and allergic rhinitis. Ranitidine is an H2 blocker historically used to suppress stomach acid.

For individuals with severe hypersensitivities or known allergies to ranitidine, accidental ingestion of cross-contaminated cetirizine presents a reasonable risk of triggering serious side effects, including:

• Anaphylaxis (severe allergic reaction)
• Hypotension (sudden drop in blood pressure)
• Dyspnea (difficulty breathing)
• Facial and throat swelling
• Hives, itching, or loss of consciousness

Action Steps for Consumers and Patients

Verify Your Bottle: Check the lot number printed on the side of your 100-count bottle label.

Discontinue Use Immediately: If your bottle matches lot numbers GY825029, GY825030, GY825031, or GY825032, stop taking the medication.

Contact Support: Consumers seeking return or reimbursement instructions can contact Rising Pharma Holdings Inc. at 1-844-874-7464 (Monday–Friday, 8 a.m. to 5 p.m. EST) or via email at [email protected].

Report Side Effects: Any adverse reactions should be reported directly to the FDA’s MedWatch Adverse Event Reporting program.

 

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