ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Ari...
FDA Recall #D-0252-2026 — Class II — December 8, 2025
Product Description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Reason for Recall
cGMP Deviations
Recalling Firm
Signature Formulations, LLC — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
570 bottles
Distribution
AZ only
Code Information
Lot #: 250505P9, Exp. Date 05/27
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated