FDA Recall D-0102-2026

Amerisource Health Services LLC · Columbus, OH

Class II Ongoing 210 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.

Quantity: 1,818 cartons

Reason for recall

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Recall record

Recall number: D-0102-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-10-16
Classified by FDA Center: 2025-10-24
FDA published: 2025-11-05
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): PRAZOSIN HYDROCHLORIDE
Generic name(s): PRAZOSIN HYDROCHLORIDE
Manufacturer(s): American Health Packaging
NDC(s): 68084-996, 68084-997
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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