December 2025 FDA Recall Parodontax by Haleon Us Holdings Llc
D-0297-2026 - Labeling
This Class III drug recall was voluntarily initiated by Haleon Us Holdings Llc on December 26, 2025 for the product Parodontax. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0297-2026
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
12-26-2025
02-04-2026
84,764 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Haleon US Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
