ORL Kids Mouthwash recall for manufacturing practice deviations in Arizona
ORL Kids Mouthwash (bubblegum flavor) is being recalled due to manufacturing process deviations. Signature Formulations, LLC initiated the voluntary recall of approximately 570 bottles distributed in Arizona.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification with no reported illnesses or injuries. The recall is precautionary based on manufacturing process deviations rather than a specific identified safety hazard.
Plain-English summary
ORL Kids Mouthwash in bubblegum flavor (16.9 oz/500 mL bottles) is being recalled by Signature Formulations, LLC due to current Good Manufacturing Practice (cGMP) deviations. The recalled product is Lot #250505P9 with an expiration date of May 27. Approximately 570 bottles were distributed exclusively in Arizona.
The recall was initiated on December 8, 2025, and classified as FDA Class II. Signature Formulations, LLC voluntarily initiated this recall through email notification to customers.
Consumers who have purchased this product should stop using it and consult with a healthcare provider if they have any health concerns. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
- Manufacturer
- Signature Formulations, LLC
- Category
- Drug — Oral Care
- Hazard
- manufacturing-defect
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 #: 250505P9
- Exp. Date 05/27
Distribution
Distributed in 1 state:
- AZ
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