Prazosin Hydrochloride — Class II drug recall D-0104-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2025-11-05, distributed nationwide. CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categor
| Recall number | D-0104-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2025-10-07 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 181,659 bottles |
| Reason classes | potency, cgmp, specification failure |
| NDC | 00093-4067, 00093-4067-01, 00093-4067-10, 00093-4068, 00093-4068-01, 00093-4068-10, 00093-4069, 00093-4069-01, 00093-4069-05, 00093-4069-52 |
| Lot numbers | 3010440A, 3010544A, 3010545A, 3010567A, 3010590A, 3010601A, 3010602A, 3010603A, 3010652A, 3010670A, 3010671A, 3010672A, 3010678A, 3010700A, 3010701A |
| Expiration dates | 2025-10, 2025-12, 2026-02, 2026-03, 2026-07, 2026-08 |
Product
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
Reason for recall
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
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-0104-2026. 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.