Phenoxybenzamine Hydrochloride Capsules — Class II drug recall D-0319-2024
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2024-02-14, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
| Recall number | D-0319-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2024-01-15 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Terminated | 2025-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 858 bottles |
| Reason classes | specification failure |
| NDC | 60219-1502-01 |
| Lot numbers | AM221153, AM230497 |
| Expiration dates | 2024-06-30 |
Product
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
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-0319-2024. 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.