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Lucky Ice Cool Mouthwash Recall 2026 After CGMP Deviations at Gold Star Distribution

Lucky Ice Cool Mouthwash is being recalled nationwide in the United States. The action targets all lots distributed by Gold Star Distribution due to CGMP deviations and insanitary conditions, including rodent exposure in the distribution center. Consumers should stop using the product immediately and contact Gold Star Distribution for guidance.

Official notice
Lucky IceGold 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
8/10

Quick Facts at a Glance

Recall Date
December 26, 2025
Hazard Level
HIGH
Brands
Lucky Ice, 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
Lucky Ice, Gold Star Distribution
Product type
Alcohol-free Mouthwash
Model numbers
All lots within expiry distributed by Gold Star Distribution.
Sizes
16.9 oz bottle, 12-count carton
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

Lucky Ice Cool Mouthwash is a consumer oral hygiene product used to freshen breath. It is marketed as alcohol-free and sold in multi-pack formats.

Why This Is Dangerous

The recall is due to CGMP deviations linked to insanitary conditions and rodent exposure in the distribution center, raising contamination concerns.

Industry Context

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

Real-World Impact

Consumers should stop use to avoid potential exposure to unsanitary conditions. The recall status is active with no incident reports in the notice.

Practical Guidance

How to identify if yours is affected

  1. Verify product label reads Lucky Ice Cool Mouthwash, 16.9 oz, 12 CT, UPC 808829108989.
  2. Confirm the item was distributed by Gold Star Distribution.
  3. Check the FDA recall page for recall number D-0284-2026.

Where to find product info

FDA recall page for D-0284-2026; recall notice from Gold Star Distribution.

What timeline to expect

Refunds or replacements timeline not specified in notice.

If the manufacturer is unresponsive

  • Escalate with FDA recall contact points.
  • File a consumer complaint with the CPSC if the distributor does not respond within a reasonable time.

How to prevent similar issues

  • Buy mouthwash from reputable retailers; check CGMP compliance statements.
  • Be alert for recall notices on FDA's recalls page.
  • Register product with your healthcare provider for guidance if using oral hygiene products.

Documentation advice

Keep recall notice, purchase receipts, and any correspondence with the distributor for records.

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Product Details

Model numbers: All lots within expiry distributed by Gold Star Distribution. Where sold: US Nationwide. When sold: Unknown. Price: Unknown.

Key Facts

  • Recall number D-0284-2026
  • Brand: Lucky Ice; Product: Cool Mouthwash, Alcohol Free, 16.9 oz, 12CT
  • Distributor: Gold Star Distribution
  • Distribution: US Nationwide
  • Hazard: CGMP insanitary conditions including rodent exposure in distribution center

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
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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