FDA recall D-0252-2026
Signature Formulations, LLC · Class II · drug
Product
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Reason for recall
cGMP Deviations
Distribution
AZ only
Key facts
- Status
- Ongoing
- Initiation date
- 2025-12-08
- Report date
- 2026-01-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Phoenix, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0252-2026