FDAFDA · Food and drugs·Recall number D-0101-2026
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
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 #: 1023526, 1023555, Expiry: 07/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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