FDA Drug recall D-0319-2024
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
- FDA Drug
- Class II
- terminated
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt by Amneal Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0319-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-01-15 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Identifiers
| code_info | Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Amneal Pharmaceuticals
- Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-…
FDA Drug · Class II · 2026-10-07 · Amneal Pharmaceuticals - Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b…
FDA Drug · Class II · 2026-09-30 · Amneal Pharmaceuticals - Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class III · 2026-06-17 · Amneal Pharmaceuticals - traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2026-04-08 · Amneal Pharmaceuticals - Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufact…
FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0319-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.