Haleon US Holdings LLC Recalls Parodontax Active Gum Health Mouthwash Due to Labeling Issues

Source: FDA · United States

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Haleon US Holdings LLC has voluntarily recalled over 84,000 bottles of Parodontax Active Gum Health mouthwash because lot numbers and expiration dates may be missing or illegible.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Haleon US Holdings LLC has initiated a voluntary Class III recall of parodontax Active Gum Health mouthwash. The recall was prompted by a labeling issue where the lot number and expiration date coding on the bottles may be missing or illegible.

Which Products Are Affected

The recall affects 84,764 bottles of mouthwash distributed nationwide in the United States. The specific product details are as follows:

  • Product Name: parodontax (cetylpyridinium chloride) ACTIVE GUM HEALTH, Mouthwash, Mint
  • Size: 16.9 FL OZ (500 mL)
  • NDC: 0135-0651-02
  • Lot Number: 0665363
  • Expiration Date: 08/31/2027
  • Recall Number: D-0297-2026

What You Should Do

Consumers who have purchased parodontax Active Gum Health mouthwash should check the packaging for a visible lot number and expiration date. If this information is missing or cannot be read, consumers can contact the recalling firm, Haleon US Holdings LLC, based in Warren, New Jersey, for further instructions regarding the affected product.

Why This Matters

This recall is classified as Class III, indicating that the use of the product is not likely to cause adverse health consequences. However, the absence of legible lot and expiration data prevents consumers and the manufacturer from accurately tracking the product's shelf life and identifying specific units in the event of future quality concerns.

Source

Information provided by the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Haleon US Holdings LLC has voluntarily recalled over 84,000 bottles of Parodontax Active Gum Health mouthwash because lot numbers and expiration dates may be missing or illegible.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.