ORL Labs, LLC recalled 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor on December 8, 2025. The recall stems from violations of current Good Manufacturing Practices (cGMP). The product was distributed only in Arizona and poses potential safety risks for children.
cGMP Deviations
Consumers and healthcare providers should stop using this product immediately. Contact Signature Formulations, LLC or your healthcare provider for guidance. Notification method: E-Mail
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The affected product is ORL Kids Mouthwash, Bubblegum Flavor, packaged in 16.9 oz. (500ml) bottles. Model Lot #: 250505P9 with an expiration date of 05/27 is part of the recall. It was distributed in Arizona only.
The recall is prompted by cGMP deviations, indicating that the product may not meet required safety and quality standards. This raises concerns regarding potential contaminants or ineffective ingredients.
No specific injury reports have been documented related to this recall. However, the high hazard level indicates a significant risk associated with its use.
Consumers should stop using the product immediately. Contact Signature Formulations, LLC or your healthcare provider for further guidance.
For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0252-2026.
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