CLASS III ONGOING Drug recall · Reported 4 Feb 2026 · FDA Enforcement Report
parodontax (cetylpyridinium chloride)Active Gum Health recalled
Haleon US Holdings is recalling parodontax (cetylpyridinium chloride)Active Gum Health, Mouthwash, Mint, distributed nationwide in the US. The recall was initiated on 26 Dec 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0297-2026
- FDA event ID
- 98198
- Recalling firm
- Haleon US Holdings, Warren, NJ
- Brand
- Parodontax
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Dec 2025
- FDA classified
- 26 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Sunscreen & Personal Care
Timeline
| 26 Dec 2025 | Recall initiated by company | |
| 26 Jan 2026 | Classified by FDA | +31 days |
| 4 Feb 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Product as listed by the FDA
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Which lots are affected?
Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Haleon US Holdings
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Gas-X Extra Strength, Simethicone 125 mg/Antigas recalled | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS II | Gas-X, Simethicone 125 mg/ Antigas recalled by Haleon US Holdings | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | Sensodyne Pronamel (Potassium nitrate recalled by Haleon US Holdings | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Non-Drowsy Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Nighttime Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |