ORL Kids Mouthwash — Class II drug recall D-0252-2026
Ongoing recall by Signature Formulations, LLC, reported 2026-01-14, distributed in AZ. cGMP Deviations
| Recall number | D-0252-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signature Formulations, LLC, Phoenix, AZ, United States |
| Recall initiated | 2025-12-08 |
| Classified | 2026-01-05 |
| Reported by FDA | 2026-01-14 |
| Distributed | AZ |
| Quantity | 570 bottles |
| Reason classes | cgmp |
| Lot numbers | 05/27, 250505P9 |
Product
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Reason for recall
cGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0252-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.