Drug & medication recalls Moderate risk

GOLD STAR DISTRIBUTION product recalled over manufacturing violations

Recall date
December 26, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
GOLD STAR DISTRIBUTION INC recalls TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS S…
Recall number
D-0277-2026
FDA classification
Class II
Brand / firm
GOLD STAR DISTRIBUTION INC
Sold / distributed
US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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