Aleve 60-Count Pain Relievers Recalled for CGMP Deviations by Gold Star Distribution (2026)
Gold Star Distribution recalls Aleve 60-count pain relievers distributed nationwide due to CGMP deviations and insanitary conditions at its distribution center. Rodent exposure and activity were reported at the facility. 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
Brands
Aleve, 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
Aleve is an over-the-counter pain reliever using naproxen sodium. The 60-count bottle is commonly used for temporary relief of minor aches and pains.
Why This Is Dangerous
The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Contamination could pose health risks if products are affected.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
If affected, consumers face potential contamination risk. The recall is active and guidance will dictate refunds or replacements.
Practical Guidance
How to identify if yours is affected
Verify packaging: 60-count bottles sold nationwide were distributed by Gold Star Distribution.
Look for recall notices or communications from Gold Star Distribution.
Check the FDA recall page for the official recall number and updates.
Where to find product info
FDA recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0262-2026
What timeline to expect
Refunds or replacements timelines are not specified. Typical processing can take weeks.
If the manufacturer is unresponsive
Document all contact attempts with Gold Star Distribution.
File a complaint with FDA if the company is nonresponsive.
How to prevent similar issues
Buy from trusted retailers and verify CGMP compliance.
Keep purchase receipts for recalls.
Follow official recall channels for updates and refunds.
Documentation advice
Keep packaging, photos of the product, recalls notices, and all correspondence with the distributor.
Product Details
Model numbers: All lots within expiry distributed by Gold Star Distribution.
Where sold: United States nationwide.
When sold: Unknown.
Price: Unknown.
Key Facts
60-count bottles
Recall number D-0262-2026
Distributor: Gold Star Distribution
Hazard: CGMP deviations and insanitary distribution-center conditions
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