FDAHealthDecember 8, 2025

Signature Formulations, LLC — ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

⚠️ cGMP Deviations

Is this relevant to me?

Geography: AZ
Source agency: FDA
Category: Health
Published: December 8, 2025

AZ only

What's affected?

Product: ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Brand: Signature Formulations, LLC
Lot code: 250505P9

Additional details

Lot #: 250505P9, Exp. Date 05/27

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 570 bottles.

View original FDA notice →

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