Prazosin Hydrochloride — Class II drug recall D-0103-2026
Ongoing recall by Amerisource Health Services LLC, reported 2025-11-05, distributed nationwide. Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic
| Recall number | D-0103-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2025-10-16 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,410 cartons |
| Reason classes | potency, specification failure |
| NDC | 60687-0572, 60687-0572-32, 60687-0572-33 |
| Lot numbers | 1016996, 1018336, 1021220, 1022421, 1025017 |
| Expiration dates | 2025-11-30, 2026-08-31 |
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
Reason for recall
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0103-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.