Amerisource Health Services LLC: Drug Recall

Recall #D-0675-2025 · 09/15/2025

Class II: Risk

Recall Details

Recall Number: D-0675-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Amerisource Health Services LLC
Status: Ongoing
Date Initiated: 09/15/2025
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 360 cartons

Reason for Recall

Failed Dissolution Specifications.

Product Description

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

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 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 →

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.