Recalls / Class II
Class IID-0102-2026
Product
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
- Brand name
- Prazosin Hydrochloride
- Generic name
- Prazosin Hydrochloride
- Active ingredient
- Prazosin Hydrochloride
- Route
- Oral
- NDCs
- 68084-996, 68084-997
- FDA application
- ANDA071745
- Affected lot / code info
- Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
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
- 1,818 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-0102-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.