What does CGMP deviations mean?

CGMP stands for Current Good Manufacturing Practices. Deviations indicate potential problems in manufacturing or distribution practices that could affect product quality and safety.

Which lots are affected?

All lots within expiry distributed by Gold Star Distribution are included in the recall.

What should I do if I have this product?

Stop using the product immediately. Contact Gold Star Distribution Inc or your healthcare provider for guidance using two or more channels (email, fax, letter, press release, telephone, or in person).

Where can I get more information?

Visit the FDA recall page linked in the notice for official details.

The recall notice instructs customers to contact Gold Star Distribution for guidance. Refund eligibility is not specified in the notice.

How can I check my lot number?

Lot numbers are printed on the bottle label. Compare against the recall notice details on the FDA page.

Is there a health risk from this recall?

The recall concerns insanitary conditions at the distribution center. No injuries are reported in the notice, but consumers should stop use and seek guidance.

Should I discard the product?

Do not use the product and follow the recall guidance from Gold Star Distribution or a healthcare provider.

What should retailers do?

Retailers should remove affected stock from shelves and direct customers to the recall notice for guidance.

How long will resolution take?

The notice does not specify a completion timeline. Monitor the FDA recall page for updates.

Who can I contact for questions?

For now, use the FDA recall page and any guidance provided by Gold Star Distribution.

HIGHDecember 26, 2025

Gold Star Distribution Motrin 2's Disp.-50ct Recall Active Over Rodent Exposure

Q: Is the Motrin 2's Disp.-50ct recalled?

Yes. The recall covers all lots within expiry distributed by Gold Star Distribution due to CGMP deviations and insanitary conditions at the distribution center.

Gold Star Distribution's Motrin 2's Disp.-50ct recall remains active after inspectors found insanitary conditions, including rodent exposure, at the distributor's facility. The recall cites CGMP deviations in the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution 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

Motrin is an over-the-counter ibuprofen pain reliever distributed by Gold Star Distribution. It is sold as a 50-count bottle under the Motrin brand.

Why This Is Dangerous

CGMP deviations in the distribution center created insanitary conditions, including rodent exposure. This raises potential contamination risk for products in the affected lots.

Industry Context

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

Real-World Impact

Consumers who received affected Motrin should stop using it immediately and seek guidance from a healthcare provider. There is no reported injury in the notice, but contamination concerns warrant caution.

Practical Guidance

How to identify if yours is affected

Locate Motrin 2's Disp.-50ct bottles in your medicine cabinet.
Check the lot within expiry distributed by Gold Star Distribution.
If uncertain, consult the FDA recall page for the affected lot details.

Where to find product info

FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0271-2026

What timeline to expect

Timeline for official refunds or replacements is not specified. Expect updates from FDA or Gold Star Distribution.

If the manufacturer is unresponsive

Document all attempts to contact Gold Star Distribution.
Consider filing a consumer safety complaint with the CPSC if there is no response after a reasonable period.

How to prevent similar issues

Purchase OTC medicines from reputable retailers.
Inspect packaging for tampering and confirm the lot and expiry dates before use.
Register products with recalls on the FDA recall list when available.

Documentation advice

Keep the product packaging, lot numbers, and any correspondence with the distributor or healthcare providers. Take photos if possible.

Product Details

Model numbers: All lots within expiry distributed by Gold Star Distribution. Sold nationwide in the United States. When sold: Unknown. Price: Unknown.

Key Facts

2025-12-26: Recall date for Motrin 2's Disp.-50ct by Gold Star Distribution
Active recall with nationwide US distribution
All lots within expiry distributed by Gold Star Distribution
Hazard: CGMP deviations and insanitary distribution conditions with rodent exposure
Injuries reported: 0

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 tablets (Motrin) 50-count bottle

Product Details

Brand

Gold Star Distribution

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