Phenoxybenzamine Hydrochloride Capsules recall
FDA recall D-0319-2024 · initiated Jan 15, 2024
Amneal Pharmaceuticals of New York, LLC recalled Phenoxybenzamine Hydrochloride Capsules in Jan 2024 — an FDA Class II recall (D-0319-2024) because Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 858 bottles
Details
- 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
- Recalling company
- Amneal Pharmaceuticals of New York, LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Jan 15, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was Phenoxybenzamine Hydrochloride Capsules recalled?
- Amneal Pharmaceuticals of New York, LLC recalled Phenoxybenzamine Hydrochloride Capsules in Jan 2024 — an FDA Class II recall (D-0319-2024) because Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phenoxybenzamine Hydrochloride Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0319-2024 was: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Is a recalled Phenoxybenzamine Hydrochloride Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenoxybenzamine Hydrochloride Capsules are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0319-2024.