The Recall Desk
HighFDA (Drugs)·D-0282-2026·Announced 2026-01-21

Carmex Lip Balm Recalled for Insanitary Conditions at Distribution Center

Gold Star Distribution Inc. is recalling Carmex lip balm products distributed nationwide due to insanitary conditions, including rodent exposure and activity, found at their distribution center during a CGMP inspection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a CGMP deviation with potential contamination hazard (insanitary conditions and rodent exposure). No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) score.

Plain-English summary

Gold Star Distribution Inc. is recalling Carmex lip balm products consisting of both jar and tube formats with the following UPCs: 083078123154, 083078113155 (jars, 12 count), and 083078123147, 083078113148 (tubes with PEG, 12 count). All lots within their expiration date that were distributed by Gold Star Distribution are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered at the company's distribution center, specifically insanitary conditions including evidence of rodent exposure and activity. These conditions create a potential risk of product contamination.

The affected products were distributed nationwide. Consumers who have purchased these Carmex products should stop using them and consider consulting a healthcare provider if they have concerns about their use.

For questions or to report adverse events related to this product, consumers should contact Gold Star Distribution Inc. or the FDA.

The recalled product

Product
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
Manufacturer
GOLD STAR DISTRIBUTION INC
Category
Drug — Over-the-Counter Topical
Hazard
  • rodent-exposure
  • sanitation-violation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry distributed by Gold Star Distribution.

Distribution

Distributed nationwide across the United States.

Related recalls

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