Prazosin Hydrochloride Capsule
FDA Recall NDC 0093-4069
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Prazosin Hydrochloride (NDC 0093-4069). A significant event, classified as Class II, was initiated on Oct 07, 2025 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
October 2025 Class II 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.
Recall Number
Class II Ongoing
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.
Oct 07, 2025
Nov 05, 2025
291,512 bottles
Recall Profile & Regulatory Data
Event ID
97755
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Batch or Lot Expiration Information
Lot# a) NDC 0093-4068-01:
Lot# 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025
Lot# 3010439A, 3010388A, Exp Date: 01/2026
Lot# 3010526A, 3010527A, Exp Date: 03/2026
Lot# 3010591A, 07/2026
Lot# 3010343A, Exp Date: 10/2025
Lot# 3010352A, Exp Date: 11/2025
Lot# 3010468A, 3010469A, 3010461A, Exp Date: 02/2026
Lot# 3010629A, Exp Date: 09/2026
Lot# 3010653A, Exp Date: 01/2027
Lot# 3010654A, 3010679A, 3010702A, Exp Date: 02/2027
Lot# 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10:
Lot# 3010402A Exp Date: 02/2028
Lot# 3010593A, Exp Date: 07/2026
Lot# 3010610A, Exp Date: 09/2026
Affected Packages Involved in this Recall
0093-4067-01Product
0093-4067-10Product
0093-4068-01Product
0093-4068-10Product
0093-4069-01Product
0093-4069-52Product
0093-4069-05Product
October 2025 Class II 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.
Recall Number
Class II Ongoing
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.
Oct 07, 2025
Nov 05, 2025
181,659 bottles
Recall Profile & Regulatory Data
Event ID
97755
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# a) NDC 0093-4067-01:
Lot# 3010544A and 3010545A, Exp Date: 10/2025
Lot# 3010567A, Exp Date: 12/2025
Lot# 3010590A, Exp Date: 02/2026
Lot# 3010601A, 3010602A, 3010603A, Exp Date: 03/2026
Lot# 3010652A, 3010670A, 3010671A, Exp Date: 07/2026
Lot# 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC 0093-4067-10:
Lot# 3010440A, Exp Date: 12/2025
Lot# 3010672A, Exp Date: 07/2026
Affected Packages Involved in this Recall
0093-4067-01Product
0093-4067-10Product
0093-4068-01Product
0093-4068-10Product
0093-4069-01Product
0093-4069-52Product
0093-4069-05Product
October 2025 Class II 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.
Recall Number
Class II Ongoing
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.
Oct 07, 2025
Nov 05, 2025
107,673
Recall Profile & Regulatory Data
Event ID
97755
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0093-4067-01Product
0093-4067-10Product
0093-4068-01Product
0093-4068-10Product
0093-4069-01Product
0093-4069-52Product
0093-4069-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
