FDA Recall D-0252-2026

Signature Formulations, LLC · Phoenix, AZ

Class II Ongoing 157 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 570 bottles

Reason for recall

cGMP Deviations

Recall record

Recall number: D-0252-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: AZ only
Recall initiated: 2025-12-08
Classified by FDA Center: 2026-01-05
FDA published: 2026-01-14
Recalling firm: Signature Formulations, LLC
Firm location: Phoenix, AZ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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