Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
Reported: November 5, 2025 Initiated: October 16, 2025 #D-0103-2026
Product Description
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
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
- 3,410 cartons
- Distribution
- Nationwide within the United States
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33. Recalled by Amerisource Health Services LLC. Units affected: 3,410 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-0103-2026.
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