Recalls / Class II
Class IID-0103-2026
Product
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
- Brand name
- Prazosin Hydrochloride
- Generic name
- Prazosin Hydrochloride
- Active ingredient
- Prazosin Hydrochloride
- Route
- Oral
- NDC
- 60687-572
- FDA application
- ANDA071745
- Affected lot / code info
- Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
Why it was recalled
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 3,410 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-10-16
- FDA classified
- 2025-10-24
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0103-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.