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Recall Observatory FDA recall evidence

Drug product

Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181

D-0278-2026

December 26, 2025

Class II

Product summary

Firm
GOLD STAR DISTRIBUTION INC
Event
Event 98239
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0278-2026

Official wording

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

Code information: All lots within expiry distributed by Gold Star Distribution.

Distribution pattern: US Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations