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D-0252-2026 Class II Ongoing

Recalled by Signature Formulations, LLC — Phoenix, AZ

FDA drug recall D-0252-2026 was initiated by Signature Formulations, LLC on December 8, 2025 and is designated Class II. Reason for recall: cGMP Deviations The recall status is ongoing. Affected quantity: 570 bottles.

Recall Details

Product Type: Drugs
Report Date: January 14, 2026
Initiation Date: December 8, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 570 bottles

Product Description

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

Reason for Recall

cGMP Deviations

Distribution Pattern

AZ only

Code Information

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