FDA-Drug2026-01-21Class IIPROCESSING DEFECT

Tylenol products recalled for rodent contamination at distribution center

MOLDOTHERNationwide distribution

Stop using recalled Tylenol products

Several Tylenol products distributed by Gold Star Distribution Inc. were stored in conditions where rodents were present at their distribution center. This poses a potential contamination risk. The recall affects multiple Tylenol formulations including 500 mg, Cold & Flu, Cold & Flu Severe, PM, and Sinus Severe products nationwide.

  • Check your medicine cabinet for affected Tylenol products distributed by Gold Star Distribution
  • Do not use any recalled products
  • Return them to the pharmacy or place of purchase for a refund or replacement
  • Contact the FDA or your pharmacist if you have questions about whether your product is affected
Hazard

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

Sold states
US Nationwide.
Manufactured in
1000 Humboldt Ave N, Minneapolis, MN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2026

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