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Class III: unlikely to cause harmOngoing

Haleon US Holdings parodontax Recall

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint

Haleon US Holdings LLC · Warren, NJ

Risk level
Class III
Reported by FDA
Feb 4, 2026
Recall ID
D-0297-2026
Check your lot numberHow we source this data

Summary

Haleon US Holdings recalled parodontax starting Dec 26, 2025. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0297-2026 on Feb 4, 2026. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. Status: Ongoing.

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.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0297-2026
Classification
Class III
Status
Ongoing
Recall initiated
Dec 26, 2025
FDA report date
Feb 4, 2026
Quantity
84,764 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Haleon US Holdings LLC

Original FDA data

Every field from FDA enforcement report D-0297-2026, exactly as published.

Show all FDA fields
City
Warren
State
NJ
Status
Ongoing
Country
United States
Event ID
98198
Address
184 Liberty Corner Rd Ste 200
Code information
Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
Postal code
07059-6870
Report date
Feb 4, 2026
Product type
Drugs
Recall number
D-0297-2026
Classification
Class III
Recalling firm
Haleon US Holdings LLC
Product quantity
84,764 bottles
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Dec 26, 2025
Initial firm notification
Letter
Center classification date
Jan 26, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0297-2026, published Feb 4, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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