FDA Drug Recalls

Recalls / Class II

Class IID-0278-2026

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

Affected lot / code info
All lots within expiry distributed by Gold Star Distribution.

Why it was recalled

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

Recalling firm

Firm
GOLD STAR DISTRIBUTION INC
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
1000 Humboldt Ave N, Minneapolis, Minnesota 55411-3964

Distribution

Distribution pattern
US Nationwide.

Timeline

Recall initiated
2025-12-26
FDA classified
2026-01-14
Posted by FDA
2026-01-21
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0278-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.