Parodontax Mouthwash
FDA Recall NDC 0135-0650
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Parodontax (NDC 0135-0650). A significant event, classified as Class III, was initiated on Dec 26, 2025 by Haleon Us Holdings Llc. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Dec 26, 2025
Feb 04, 2026
84,764 bottles
Recall Profile & Regulatory Data
Event ID
98198
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Haleon US Holdings LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Affected Packages Involved in this Recall
0135-0651-02Product
0135-0651-03Product
0135-0650-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
