US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 8, 2025 (9 months ago)

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations

What was recalled

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

Recalling firm
Signature Formulations, LLC
Origin
AZ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0252-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.