FDAFDA · Food and drugs·Recall number D-0103-2026
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
Published November 5, 2025 · Recall initiated: October 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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