What is being recalled?

Gold Star Distribution is recalling Advil Ibuprofen Dispenser Pack products sold nationwide in the United States. The recall covers two packaging formats and UPCs 305730154895 and 305730164559.

Why is the recall issued?

The recall cites CGMP deviations due to insanitary conditions with rodent exposure at the distributor's center. This raises a potential contamination risk.

Are there injuries related to this recall?

The recall notice does not report any injuries or deaths to date.

How can I check if my product is affected?

Verify packaging as Advil Ibuprofen Dispenser Pack with two tablet packets in a box of 50 or two caplet packets in a box of 50. UPCs are 305730154895 and 305730164559. All lots within expiry distributed by Gold Star Distribution are included.

Where was the product sold?

Distributed nationwide in the United States through Gold Star Distribution.

What if I need a refund or replacement?

Follow the distributor's notification method and instructions for refund or replacement. This typically involves email, fax, letter, press release, telephone, or in-person contact.

Will there be a time frame for refunds?

Companies typically process refunds or replacements within several weeks; the recall timeline is not specified and may vary.

Should I contact my doctor?

Yes, consult your healthcare provider for guidance before using any pain relief medication during this recall.

Where can I find official recall information?

Refer to the FDA enforcement report for recall D-0261-2026 and the Gold Star Distribution notices.

What should I do with the recalled product if I can’t get a replacement yet?

Keep the product secured and follow the distributor's instructions; document attempts to contact the company.

Will other Advil products be affected?

The recall specifically covers the Advil Ibuprofen Dispenser Pack formats described; other Advil products are not indicated in this recall.

HIGHDecember 26, 2025

Gold Star Distribution Recalls Advil Ibuprofen Dispenser Pack Over Rodent Exposure (2026)

Q: What should I do if I own this product?

Stop using the product immediately. Contact Gold Star Distribution Inc. or your healthcare provider for guidance.

Gold Star Distribution recalled Advil Ibuprofen Dispenser Pack distributed nationwide after CGMP deviations and rodent exposure at its distribution center. The recall covers two formats with UPCs 305730154895 and 305730164559. Consumers should stop using the product and contact the distributor or their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date: December 26, 2025
Hazard Level: HIGH
Brand: GOLD STAR DISTRIBUTION
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact GOLD STAR DISTRIBUTION INC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

The Advil Ibuprofen Dispenser Pack is a distribution format of standard ibuprofen intended for convenient dosing. It is sold as a consumer pain reliever in two packaging formats.

Why This Is Dangerous

Insanitary distribution-center conditions, including rodent exposure, create a potential contamination risk for drugs before they reach consumers.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Consumers could be exposed to contaminated medication due to unsanitary handling. No injuries are reported, but the recall emphasizes immediate cessation of use and guidance from the distributor or a healthcare professional.

Practical Guidance

How to identify if yours is affected

Check if you have Advil Ibuprofen Dispenser Pack with UPC 305730154895 or UPC 305730164559.
Confirm packaging contains two tablet or two caplet packets in a box of 50.
Verify that the product was distributed by Gold Star Distribution and is within expiry.

Where to find product info

FDA recall enforcement page for D-0261-2026 and Gold Star Distribution notices.

What timeline to expect

Refund or replacement generally takes 4-8 weeks after submission, depending on the distributor's process.

If the manufacturer is unresponsive

File a complaint with the FDA or your local consumer protection agency if the distributor is slow to respond.
Keep records of all communications and the product details.

How to prevent similar issues

Buy medications from reputable retailers and verify packaging before purchase.
When buying OTC pain relievers, check for CGMP compliance indicators and verify expiration dates.
Be cautious of products from distributors with sanitation concerns.

Documentation advice

Keep the product packaging, UPCs, purchase receipt, and all correspondence with the distributor. Take photos if needed.

Product Details

UPC 305730154895 for Advil Ibuprofen Dispenser Pack with 2 tablet packets in a box of 50 packets. UPC 305730164559 for PM Ibuprofen Dispenser Pack with 2 caplet packets in a box of 50 packets. All lots within expiry distributed by Gold Star Distribution. Sold in the United States nationwide. Recall number D-0261-2026. Recall date 2025-12-26. Status: ACTIVE.

Key Facts

Recall number D-0261-2026
Recall date 2025-12-26; Report date 2026-01-21
Brand: Gold Star Distribution
Product: Advil Ibuprofen Dispenser Pack (two formats)
UPC: 305730154895 and 305730164559
Distribution: US nationwide; All lots within expiry

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeIbuprofen Dispenser Pack

Product Details

Dec 26, 2025

GOLD STAR DISTRIBUTION

CGMP Deviations: