HIGHFDA DRUG

Gold Star Distribution Ice Gel 8oz 12-Count Recalled for CGMP Violations (2026)

Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.

Official notice
Gold Star DistributionHealth & Personal CareDrugs & MedicationsAll lots within expiry distributed by Gold Star Distribution.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 26, 2025
Status
ACTIVE
Severity
7/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Gold Star Distribution
Product type
Ice Gel
Model numbers
All lots within expiry distributed by Gold Star Distribution.
Sizes
8oz
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 26, 2025

  2. Reported by FDA DRUG

    January 21, 2026

  3. RecallRadar source check

    March 18, 2026

  4. 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

This is a personal care cooling gel sold in 12-count packaging as an 8oz unit. It is used for topical cooling relief.

Why This Is Dangerous

Insanitary CGMP conditions at the distribution center raise contamination concerns for products in distribution.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face potential contamination risk. The recall is active; stop use immediately to mitigate any risk.

Practical Guidance

How to identify if yours is affected

  1. Check the packaging for 8oz Ice Gel in 12-count packaging with UPC 048155903463
  2. Verify distributor as Gold Star Distribution
  3. Check expiry date and lot code on packaging (if present)

Where to find product info

FDA recall page and Gold Star Distribution notices; packaging labels

What timeline to expect

Refunds or replacements, if offered, may take 4-8 weeks to process

If the manufacturer is unresponsive

  • Document all communications with the distributor
  • File a consumer complaint with CPSC or FDA if the company remains unresponsive
  • Consult a lawyer for serious injuries or unresponsive supplier

How to prevent similar issues

  • Buy cooling gels from reputable brands with CGMP compliance
  • Verify packaging and UPC during purchase
  • Monitor recall notices and respond promptly

Documentation advice

Keep recall notices, product packaging, UPC, and any correspondence as records

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Product Details

Brand: Gold Star Distribution Product: Ice Gel, 8oz, 12-count UPC: 048155903463 Recall Number: D-0281-2026 Recall Date: 2025-12-26 Distribution: US Nationwide Sold By: All lots within expiry distributed by Gold Star Distribution Model numbers: All lots within expiry distributed by Gold Star Distribution Price: Unknown Date codes: Unknown Country of origin: Unknown

Key Facts

  • 8oz Ice Gel packaging in 12-count units affected
  • UPC 048155903463 identified on product
  • Recall active as of 2026-01-21
  • No reported injuries or deaths
  • Distributor: Gold Star Distribution Inc; nationwide distribution in the US

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
All lots within expiry distributed by Gold Star Distribution.
Affected States
ALL
Report Date
January 21, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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