Recalls / Class II
Class IID-0261-2026
Product
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
- 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
- Unkown
- 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-0261-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.