FDA Recall D-0297-2026
Haleon US Holdings LLC · Warren, NJ
Class III Ongoing 139 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
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.
Recall record
- Recall number
D-0297-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-12-26
- Classified by FDA Center
- 2026-01-26
- FDA published
- 2026-02-04
- Recalling firm
- Haleon US Holdings LLC
- Firm location
- Warren, NJ
Drug identification
- Brand name(s)
- PARODONTAX
- Generic name(s)
- CETYLPYRIDINIUM CHLORIDE
- Manufacturer(s)
- Haleon US Holdings LLC
- NDC(s)
0135-0650, 0135-0651- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.