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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ORL Kids Mouthwash is designed for children, providing a fun bubblegum flavor to encourage dental hygiene. Parents often purchase it to promote good oral care habits in kids.
The cGMP deviations indicate that the manufacturing process may have compromised the product's safety and quality. This can lead to potential contamination or ineffective ingredients in the mouthwash.
This recall is not part of a broader industry pattern.
Consumers may face safety concerns regarding the effectiveness and safety of the mouthwash, leading to a need for immediate disposal or return.
The Lot number and expiration date are typically found near the bottom of the bottle or on the label.
Expect a refund or guidance response within 4-6 weeks.
Keep receipts, product packaging, and any correspondence regarding the recall as records.
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.
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