parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 m...

FDA Drug Recall #D-0297-2026 - Class III, December 26, 2025

Recall Summary

Recall Number D-0297-2026
Classification Class III, Low risk
Date Initiated December 26, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Haleon US Holdings LLC
Location Warren, NJ
Product Type Drugs
Quantity 84,764 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

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.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

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

Other Recalls from Haleon US Holdings LLC

Recall # Classification Product Date
D-0595-2026 Class I Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGA... Jun 4, 2026
D-0542-2026 Class II Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGel... May 11, 2026
D-0592-2025 Class III Sensodyne PRONAMEL (Potassium nitrate 5%, Sodiu... Aug 5, 2025
D-0317-2024 Class I Robitussin Honey CF Max Nighttime Adult (Acetam... Dec 26, 2023
D-0316-2024 Class I Robitussin Honey CF Max Non-Drowsy Adult (Aceta... Dec 26, 2023

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.