FDA Drug recall D-0106-2026
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules… by Teva Pharmaceuticals Usa, citing 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 specifi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0106-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-07 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
Reason
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.
Identifiers
| ndc | 0093-4067-01 |
|---|---|
| ndc | 0093-4067-10 |
| ndc | 0093-4068-01 |
| ndc | 0093-4068-10 |
| ndc | 0093-4069-01 |
| ndc | 0093-4069-52 |
| ndc | 0093-4069-05 |
| code_info | a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354…a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05: Lot # 3010406A, Exp Date: 02/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0106-2026%22
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