FDA Recall D-0278-2026

GOLD STAR DISTRIBUTION INC · Minneapolis, MN

Class II Ongoing 139 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: All lots within expiry distributed by Gold Star Distribution.

Reason for recall

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

Recall record

Recall number: D-0278-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US Nationwide.
Recall initiated: 2025-12-26
Classified by FDA Center: 2026-01-14
FDA published: 2026-01-21
Recalling firm: GOLD STAR DISTRIBUTION INC
Firm location: Minneapolis, MN

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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