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Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by A...

FDA Recall #D-0103-2026 — Class II — October 16, 2025

Recall #D-0103-2026 Date: October 16, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Amerisource Health Services LLC — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,410 cartons

Distribution

Nationwide within the United States

Code Information

Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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