parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH recall
FDA recall D-0297-2026 · initiated Dec 26, 2025
Haleon US Holdings LLC recalled parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH in Dec 2025 — an FDA Class III recall (D-0297-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 84,764 bottles
Details
- Product
- 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
- Recalling company
- Haleon US Holdings
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 26, 2025
- FDA report date
- Feb 4, 2026
Frequently asked
- Was parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH recalled?
- Haleon US Holdings LLC recalled parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH in Dec 2025 — an FDA Class III recall (D-0297-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH recalled?
- Per the FDA enforcement record, the reason for recall D-0297-2026 was: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
- Is a recalled parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0297-2026.