Recalls / Class III
Class IIID-0297-2026
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
- Brand name
- Parodontax
- Generic name
- Cetylpyridinium Chloride
- Active ingredient
- Cetylpyridinium Chloride
- Route
- Oral
- NDCs
- 0135-0650, 0135-0651
- FDA application
- M022
- Affected lot / code info
- Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
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.
Recalling firm
- Firm
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd Ste 200, N/A, Warren, New Jersey 07059-6870
Distribution
- Quantity
- 84,764 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-26
- FDA classified
- 2026-01-26
- Posted by FDA
- 2026-02-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0297-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.