D-0261-2026 Class II Ongoing
FDA drug recall D-0261-2026 was initiated by GOLD STAR DISTRIBUTION INC on Dec 26, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. The recall status is ongoing. Affected quantity: Unkown.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 21, 2026
- Initiation Date
- Dec 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unkown
Product Description
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 Pattern
US Nationwide.
Code Information
All lots within expiry distributed by Gold Star Distribution.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0261-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026