RecallRadar

FDA Drug recall D-0252-2026

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

On 2026-01-14 the FDA classified a Class II recall of ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA by Signature Formulations, citing cGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0252-2026
ClassificationClass II
Statusongoing
Initiated2025-12-08
Published2026-01-14
Last updated2026-09-13 11:52 UTC
CompanySignature Formulations
DistributionAZ

Product

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

Reason

cGMP Deviations

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0252-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.