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
Reported: November 5, 2025 Initiated: October 16, 2025 #D-0101-2026
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
Reason for Recall
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 1,970 cartons
- Distribution
- Nationwide within the United States
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerisource Health Services LLC. Units affected: 1,970 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0101-2026.
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