D-0277-2026Class II

GOLD STAR DISTRIBUTION INC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-01-21

Distribution

US Nationwide.

Firm state

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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

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

Code / lot info

All lots within expiry distributed by Gold Star Distribution.

Other recalls SPEQ maps to Risk Management & CAPA

2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.

See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.