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

FDA Recall #D-0277-2026 — Class II — December 26, 2025

Recall #D-0277-2026 Date: December 26, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

GOLD STAR DISTRIBUTION INC — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

US Nationwide.

Code Information

All lots within expiry distributed by Gold Star Distribution.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated