Recall Issued for Parodontax Active Gum Health Mouthwash Due to Labeling Error

Key Takeaways

• Haleon has voluntarily recalled 84,764 bottles of parodontax Active Gum Health Mouthwash (cetylpyridinium chloride), 16.9 fl oz, distributed nationwide under NDC 0135-0651-02.
• The FDA classified the action as a Class III recall due to potentially missing or illegible lot number and expiration date labeling on 500 mL bottles.
• No safety concerns are expected; however, pharmacists should review inventory for traceability and ensure proper patient counseling regarding product identification.

The US Food and Drug Administration (FDA) has announced a voluntary nationwide recall of parodontax (cetylpyridinium chloride) Active Gum Health Mouthwash, Mint, in the 16.9 fl oz (500 mL) bottle. The product is distributed by Haleon US Holdings LLC, Warren, New Jersey. A total of 84 764 bottles are affected. The recall is identified under Recall Number D-0297-2026 and Event ID 98198, with distribution occurring throughout the US. The recall remains ongoing.

This action has been classified by the FDA as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences. The recall was firm-initiated and voluntary, with initial notification issued via letter. Although the affected lot is lot #0665363 with an expiration date of August 31, 2027. The FDA notes that the lot number and expiration date may be missing or illegible on the 500 mL bottles, prompting the labeling concern.

The recall was initiated due to incorrect or missing lot and/or expiration date coding on the bottles. While this issue does not pose a direct safety risk, proper lot and expiration date labeling is required for product traceability, inventory control, and consumer confidence. No press release has been issued for this recall, and the FDA has not provided a termination date. Pharmacists should be aware of this recall when managing inventory and advising patients.

Parodontax Active Gum Health Mouthwash contains cetylpyridinium chloride, an antiseptic agent used to help reduce plaque bacteria, support gum health, and promote oral hygiene as part of a daily oral care routine.