Mouthwash recalled over missing or illegible lot and expiry coding
Haleon is recalling 84,764 bottles of parodontax Active Gum Health Mouthwash, Mint, over the potential for missing or illegible lot and expiration date coding on the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the record cites missing or illegible lot and expiry coding with no product defect or stated consequence.
Plain-English summary
Parodontax (cetylpyridinium chloride) Active Gum Health Mouthwash, Mint, net weight 16.9 FL OZ (500 mL), under NDC 0135-0651-02, distributed by Haleon of Warren, New Jersey, is being recalled by Haleon US Holdings LLC.
The reason given in the enforcement record is a labeling issue: the potential for missing or illegible lot and expiration date coding on the bottles.
The record lists 84,764 bottles from lot 0665363, expiry 08/31/2027, and notes that the lot number and expiry date may not appear on the 500 mL bottle. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
The record cites missing or illegible code printing rather than any defect in the product itself, and reports no injuries. Consumers should follow the retailer's return instructions.
The recalled product
- Product
- PARODONTAX (CETYLPYRIDINIUM CHLORIDE)
- Brand
- PARODONTAX
- Manufacturer
- Haleon US Holdings LLC
- Category
- Drug — Mouthwash
- Affected units
- 84,764
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0665363
- Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
Distribution
Distributed nationwide across the United States.
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