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Drug FDA Class II Ongoing cGMP deviation

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

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 · primaryInsanitary conditions

Affected products (1)

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
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-0277-2026
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.