CLASS II Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled
Amneal Pharmaceuticals of New York is recalling Phenoxybenzamine Hydrochloride Capsules, USP 10mg, distributed nationwide in the US. The recall was initiated on 15 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0319-2024
- FDA event ID
- 93813
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2024
- FDA classified
- 8 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Jan 2024 | Recall initiated by company | |
| 8 Feb 2024 | Classified by FDA | +24 days |
| 14 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Which lots are affected?
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Phenoxybenzamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Par Formulations Private | Potency & Assay | Nationwide |