Amerisource Health Services LLC: Drug Recall

Recall Details

Recall Number

D-0103-2026

Classification

Class II

Product Type

Drug

Recalling Firm

Amerisource Health Services LLC

Status

Ongoing

Date Initiated

10/16/2025

Location

Columbus, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3,410 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

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Amerisource Health Services LLC

• Class II: Risk 10/16/2025
  Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
• Class II: Risk 10/16/2025
  Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
• Class II: Risk 10/09/2025
  CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
• Class II: Risk 09/15/2025
  Failed Dissolution Specifications.
• Class II: Risk 08/27/2025
  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

View all recalls by Amerisource Health Services LLC →