Drug & medication recalls Moderate risk

ORL Kids Mouthwash recalled over manufacturing violations

Recall date
December 8, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Signature Formulations, LLC recalls ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Recall number
D-0252-2026
FDA classification
Class II
Brand / firm
Signature Formulations, LLC
Sold / distributed
AZ only

Why it was recalled

cGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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