FDA DrugsClass III
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt ...
Published: February 4, 2026Recall ID: D-0297-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | D9OM4SK49P |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 1100924 |
| Openfda › Spl id | 34a4093a-3aa9-3c7b-e063-6294a90a961a |
| Openfda › Brand name | PARODONTAX |
| Openfda › Spl set id | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 |
| Openfda › Package ndc › 1 | 0135-0651-02 |
| Openfda › Package ndc › 2 | 0135-0651-03 |
| Openfda › Package ndc › 3 | 0135-0650-01 |
| Openfda › Product ndc › 1 | 0135-0650 |
| Openfda › Product ndc › 2 | 0135-0651 |
| Openfda › Generic name | CETYLPYRIDINIUM CHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CETYLPYRIDINIUM CHLORIDE |
| Openfda › Manufacturer name | Haleon US Holdings LLC |
| Openfda › Application number | M022 |
| Openfda › Is original packager | true |
| Event id | 98198 |
| Address 1 | 184 Liberty Corner Rd Ste 200 |
| Address 2 | N/A |
| Code info | Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle. |
| Postal code | 07059-6870 |
| Report date | 20260204 |
| Product type | Drugs |
| Product quantity | 84,764 bottles |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251226 |
| Initial firm notification | Letter |
| Center classification date | 20260126 |
Overview
- Recalling FirmHaleon US Holdings LLC
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the USA