FDA DrugsClass II
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC...
Published: January 14, 2026Recall ID: D-0252-2026Category: drugsCountry: US
Reason for Recall / Hazard
cGMP Deviations
Product Description & Identification
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Additional Source Details
| Field | Value |
|---|---|
| City | Phoenix |
| State | AZ |
| Event id | 98131 |
| Address 1 | 5446 W Roosevelt St Ste 101 |
| Code info | Lot #: 250505P9, Exp. Date 05/27 |
| Postal code | 85043-2729 |
| Report date | 20260114 |
| Product type | Drugs |
| Product quantity | 570 bottles |
| Reason for recall | cGMP Deviations |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251208 |
| Initial firm notification | |
| Center classification date | 20260105 |
Overview
- Recalling FirmSignature Formulations, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionAZ only