Haleon US Holdings LLC Recalls Parodontax Active Gum Health Mouthwash Due to Labeling Issues
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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.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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 ↗
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