HIGHFDA DRUG

Carmex Lip Balm Recalled by Gold Star Distribution for 12-Count Jars and Tubes (2026)

Gold Star Distribution Inc. is recalling Carmex lip balm in 12-count jars and 12-count tubes distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

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, PREGNANT

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
Lip Balm
Model numbers
All lots within expiry distributed by Gold Star Distribution.
Sizes
12-count packaging
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

Carmex lip balm is a widely used lip moisturizer marketed for everyday lip care. The products covered are 12-count jars and 12-count tubes. Consumers use Carmex to relieve dry lips and moisture loss in daily routines.

Why This Is Dangerous

The hazard stems from CGMP deviations and insanitary conditions at the distribution center, including rodent exposure activity. The risk is potential contamination of product prior to distribution to consumers.

Industry Context

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

Real-World Impact

The recall targets products distributed nationwide in the US. No injuries are reported in the notice. Consumers should stop use to minimize potential exposure risk.

Practical Guidance

How to identify if yours is affected

  1. 2) Confirm packaging is Carmex lip balm, 12-count jars or tubes.
  2. 3) If matched, discontinue use immediately and follow the recall guidance.

Where to find product info

Recall details are posted on the FDA enforcement page linked in the notice and the recall URL provided.

What timeline to expect

No refunds or replacement timelines are specified in the notice. Consumers should await official guidance from Gold Star Distribution.

If the manufacturer is unresponsive

  • Escalate to consumer protection agencies if Gold Star Distribution is unresponsive; document all attempts to contact the company.
  • Keep copies of the recall notice and all correspondence.

How to prevent similar issues

  • Buy from reputable retailers, verify CGMP compliance of suppliers, and question any sanitation concerns at distribution centers before purchasing large quantities.
  • Check UPCs during purchase and keep receipts to aid future recall follow-ups.

Documentation advice

Maintain packaging, UPCs, date codes if present, and all recall notices and correspondence with the company.

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Product Details

- Jar lip balm, 12-count. UPCs: 083078123154; 083078113155. Sold nationwide in the US. Model: All lots within expiry distributed by Gold Star Distribution. Price: Unknown. - Tube lip balm, 12-count. UPCs: 083078123147; 083078113148. Sold nationwide in the US. Model: All lots within expiry distributed by Gold Star Distribution. Price: Unknown.

Key Facts

  • 12-count Carmex lip balm jars and tubes recalled
  • UPCs for jars: 083078123154 and 083078113155
  • Distribution: US Nationwide
  • Status: ACTIVE (high-hazard)

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
GENERALPREGNANT
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

Related Recalls

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Gold Star Distribution Recalls Claritin Over Rodent Contamination

Gold Star Distribution recalled Claritin, 20 Count, on December 26, 2025, due to insanitary conditions resulting from rodent exposure. The recall affects an unknown quantity distributed nationwide. Consumers should stop using the product immediately.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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