FDA-Drug2026-01-21Class IIPROCESSING DEFECT

Aleve 1's 60-count recalled for insanitary conditions and rodent exposure at distributor

OTHERNationwide distribution

Stop using Aleve 1's from Gold Star Distribution

Gold Star Distribution Inc. distributed Aleve 1's (60-count bottles) that were stored in conditions that did not meet safety standards. The distribution center had insanitary conditions and evidence of rodent activity. All unexpired lots distributed by this company are affected.

  • Stop using Aleve 1's purchased from Gold Star Distribution
  • Check the package or receipt to see if your product came from this distributor
  • Return the product to where you bought it or contact the manufacturer for guidance
  • Contact your doctor or poison control (1-800-222-1222) if you have health concerns
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
Aleve 1's, 60 CT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0262-2026

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