HIGH

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

  1. Verify packaging: 60-count bottles sold nationwide were distributed by Gold Star Distribution.
  2. Look for recall notices or communications from Gold Star Distribution.
  3. 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
  • Geography: US nationwide
  • Action: Stop use immediately and await guidance

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONINGOTHER

Product Details

Affected States
ALL
Report Date
January 21, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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