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Recall Observatory FDA recall evidence

Drug 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

D-0297-2026

December 26, 2025

Class III

Product summary

Firm
Haleon US Holdings LLC
Event
Event 98198
Status
Ongoing
Classification
Class III
Quantity
84,764 bottles
Official record key
drug-enforcement:D-0297-2026

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

Code information: Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing