FDA Drug Recalls

Recalls / Class II

Class IID-0266-2026

Product

Claritin, 20 Count, UPC: 655708016305

Affected lot / code info
All lots within expiry distributed by Gold Star Distribution.

Why it was recalled

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Recalling firm

Firm
GOLD STAR DISTRIBUTION INC
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
1000 Humboldt Ave N, Minneapolis, Minnesota 55411-3964

Distribution

Quantity
Unknown
Distribution pattern
US Nationwide.

Timeline

Recall initiated
2025-12-26
FDA classified
2026-01-14
Posted by FDA
2026-01-21
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0266-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls