Recalls / Class II
Class IID-0277-2026
Product
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
- 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
- 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-0277-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.