Class II · ModerateRecall completed
Phenoxybenzamine Hydrochloride Capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
| Distributed by / for | Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 |
| NDC | 60219-1502-01 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Distribution | USA nationwide. |
| Quantity | 858 bottles |
| Recall initiated | 2024-01-15 |
| Report date | 2024-02-14 |
| Recall completed | 2025-01-31 |
| Recall number | D-0319-2024 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.