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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Aleve, Gold Star Distribution
- Product type
- Pain reliever (Naproxen Sodium)
- Sizes
- 60 count
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 26, 2025
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- Recall number D-0262-2026
- Distributor: Gold Star Distribution
- Hazard: CGMP deviations and insanitary distribution-center conditions
- Geography: US nationwide
- Action: Stop use immediately and await guidance
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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