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D-0253-2026 Class II Ongoing

Recalled by Signature Formulations, LLC — Phoenix, AZ

FDA drug recall D-0253-2026 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: 1,458 containers.

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: 1,458 containers

Product Description

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

Reason for Recall

cGMP Deviations

Distribution Pattern

AZ only

Code Information

Lot #: 250520P4, Exp. Date 05/27