Prazosin Hydrochloride Capsule
FDA Recall NDC 68084-997
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Prazosin Hydrochloride (NDC 68084-997). A significant event, classified as Class II, was initiated on Oct 16, 2025 by American Health Packaging. The reported reason for this action was: "Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit"
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
Class II Ongoing
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Oct 16, 2025
Nov 05, 2025
1,818 cartons
Recall Profile & Regulatory Data
Event ID
97826
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
Batch or Lot Expiration Information
Lot# : 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
Affected Packages Involved in this Recall
68084-996-11Product
68084-996-01Product
68084-997-11Product
68084-997-01Product
Class II Ongoing
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Oct 16, 2025
Nov 05, 2025
1,970 cartons
Recall Profile & Regulatory Data
Event ID
97826
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Batch or Lot Expiration Information
Lot# : 1023526, 1023555, Expiry: 07/31/2026
Affected Packages Involved in this Recall
68084-996-11Product
68084-996-01Product
68084-997-11Product
68084-997-01Product
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.
