FDA-Drug2026-01-21Class IIPROCESSING DEFECT

Advil Ibuprofen and PM recalled for insanitary conditions at distribution center

OTHERNationwide distributionDrugs

What this means

Advil Ibuprofen and Advil PM dispenser packs distributed by Gold Star Distribution Inc. were stored in conditions that did not meet safety standards, including rodent exposure at their distribution center. The affected products were distributed nationwide. No injuries have been reported.

  • Check your Advil Ibuprofen or Advil PM dispenser packs for the UPCs 305730154895 or 305730164559
  • Do not use affected products
  • Throw away or return to the retailer where you purchased them
  • Contact FDA or your healthcare provider if you have questions
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
Unkown
Manufactured in
1000 Humboldt Ave N, Minneapolis, MN, United States
Products
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559

UPC codes

  • 305730154895
  • 305730164559

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2026

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