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Drug FDA Class II Ongoing cGMP deviation

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

GOLD STAR DISTRIBUTION INC Published Jan 21, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact GOLD STAR DISTRIBUTION INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Rodent contamination · primary

Affected products (1)

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

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 26, 2025
  2. Published
    Jan 21, 2026
Recall number
D-0278-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.