HIGHFDA DRUG

Haleon Recalls parodontax Mouthwash Over Labeling Issues

Haleon recalled 84,764 bottles of parodontax Mouthwash on December 26, 2025. The product may have missing or illegible lot and expiration dates. Consumers should stop using the mouthwash immediately.

Official notice
PARODONTAXHaleon US Holdings LLCHealth & Personal CareDrugs & MedicationsLot #: 0665363Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 26, 2025
Status
ACTIVE
Severity
7/10

Quick Facts at a Glance

Recall Date
December 26, 2025
Hazard Level
HIGH
Brands
PARODONTAX, Haleon US Holdings LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PARODONTAX, Haleon US Holdings LLC
Product type
Mouthwash
Model numbers
Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
UPC codes
0135-0650, 0135-0651, 0135-0651-02, 0135-0651-03, 0135-0650-01
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 26, 2025

  2. Reported by FDA DRUG

    February 4, 2026

  3. RecallRadar source check

    February 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Letter

About This Product

Parodontax Mouthwash is used to promote gum health and reduce plaque. Consumers purchase it for its effectiveness in maintaining oral hygiene and preventing gum disease.

Why This Is Dangerous

The recall concerns missing or illegible lot and expiration dates, which are crucial for ensuring the product's safety and effectiveness. Without this information, consumers may unknowingly use expired products.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face inconvenience from not being able to use the mouthwash and will need to seek alternatives. Immediate action is required to ensure safety.

Practical Guidance

How to identify if yours is affected

  1. Check the bottle for the lot number: 0665363.
  2. Verify if the expiration date is present and legible.
  3. Review any receipts or purchase history for this product.

Where to find product info

The lot number and expiration date are typically found near the bottom of the bottle or on the label.

What timeline to expect

Expect a refund processing timeline of approximately 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document your attempts to contact the company.
  • Reach out to the FDA if the company does not respond.

How to prevent similar issues

  • Look for clear labeling of lot and expiration dates when buying mouthwash.
  • Choose brands that have a good safety record.
  • Consider using alcohol-free or natural alternatives.

Documentation advice

Keep a copy of your receipt and any correspondence with Haleon regarding the recall.

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Product Details

The recalled product is parodontax (cetylpyridinium chloride) ACTIVE GUM HEALTH Mouthwash, Mint, with a net weight of 16.9 FL OZ (500 mL). It was distributed by Haleon, Warren, NJ, and the NDC is 0135-0651-02. The mouthwash is sold nationwide in the USA.

Key Facts

  • Recall date: December 26, 2025
  • Potential health risk from missing labeling
  • Class III recall classification

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #: 0665363
Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
UPC Codes
0135-0650
0135-0651
0135-0651-02
+2 more
Affected States
ALL
Report Date
February 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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