Amerisource Health Services LLC: Drug Recall

Recall #D-0454-2025 · 05/15/2025

Class II: Risk

Recall Details

Recall Number: D-0454-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Amerisource Health Services LLC
Status: Ongoing
Date Initiated: 05/15/2025
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21 cartons

Reason for Recall

cGMP deviations

Product Description

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).

Distribution Pattern

Nationwide in the USA

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 10/16/2025

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.

View all recalls by Amerisource Health Services LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.