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Voluntary nationwide recall: Cetirizine (Unique – July)

UPMC Health Plan·Pharmacy, Family Medicine, Internal Medicine +2 more·Pharmacy
Effective date
Jul 20, 2026
We identified it
Jul 30, 2026
Days to comply

Summary

Unique Pharmaceutical Laboratories is voluntarily recalling four specific lots of Cetirizine Hydrochloride Tablets USP 5 mg (lot numbers GY825029, GY825030, GY825031, GY825032) due to cross-contamination with Ranitidine. Affected tablets have red dots and pose a risk of severe allergic reactions in patients sensitive to Ranitidine ingredients. The billing team should alert patients and providers to verify medication lot numbers and coordinate with pharmacies on potential claim adjustments for affected prescriptions.

Action Required

Action needed
Immediately: Billing team must identify all patient claims processed for Cetirizine Hydrochloride Tablets USP 5 mg from the recalled lots (GY825029, GY825030, GY825031, GY825032) in the past 12 months. Coordinate with the pharmacy and providers to flag affected prescriptions. Alert patients to verify their medication lot numbers with their pharmacy. If patients received recalled lots, work with providers to document the medication switch and resubmit claims for non-recalled alternatives if necessary. Maintain documentation of recall response for audit purposes. Contact Rising Pharma Holdings Inc. at 844-874-7464 (TTY: 711, Monday-Friday 8am-5pm EST) or visit the FDA website for additional guidance. As of July 20, 2026, no adverse events have been reported, but monitor for patient complaints and be prepared to process adjustments or reversals if needed.