FDA recall D-0261-2026

GOLD STAR DISTRIBUTION INC · Class II · drug

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

Reason for recall

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

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-12-26
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2026