Prazosin Hydrochloride recall
FDA recall D-0103-2026 · initiated Oct 16, 2025
Amerisource Health Services LLC recalled Prazosin Hydrochloride in Oct 2025 — an FDA Class II recall (D-0103-2026) because Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 3,410 cartons
Details
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 16, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Prazosin Hydrochloride recalled?
- Amerisource Health Services LLC recalled Prazosin Hydrochloride in Oct 2025 — an FDA Class II recall (D-0103-2026) because Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Prazosin Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0103-2026 was: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
- Is a recalled Prazosin Hydrochloride 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 Prazosin Hydrochloride are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.. 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-0103-2026.