FDA Drug Recalls

Recalls / Class II

Class IID-0282-2026

Product

Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

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-0282-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.