Urodel — Class II drug recall D-0384-2025
Terminated recall by Pharmadel, LLC, reported 2025-04-30, distributed in DE. cGMP deviations
| Recall number | D-0384-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmadel, LLC, Historic New Castle, DE, United States |
| Recall initiated | 2025-04-15 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Terminated | 2026-01-08 |
| Distributed | DE |
| Quantity | 10,752 bottles |
| Reason classes | cgmp |
| NDC | 55758-0406-30 |
| Lot numbers | UDE-01 |
Product
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
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-0384-2025. 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.