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Recall Observatory FDA recall evidence

Drug product

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

D-0253-2026

December 08, 2025

Class II

Product summary

Firm
Signature Formulations, LLC
Event
Event 98131
Status
Ongoing
Classification
Class II
Quantity
1,458 containers
Official record key
drug-enforcement:D-0253-2026

Official wording

Reason: cGMP Deviations

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

Distribution pattern: AZ only

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations