US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 26, 2025 (8 months ago)

TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Gold Star Distribution INC
Origin
MN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0277-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.