Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Pack…
- Recall date
- October 16, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0101-2026
- FDA classification
- Class II
- Brand / firm
- Amerisource Health Services LLC
- Sold / distributed
- Nationwide within the United States
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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