AvKARE: Drug Recall

Recall #D-0103-2025 · 10/18/2024

Class II: Risk

Recall Details

Recall Number: D-0103-2025
Classification: Class II
Product Type: Drug
Recalling Firm: AvKARE
Status: Ongoing
Date Initiated: 10/18/2024
Location: Pulaski, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 bottles

Reason for Recall

Labeling: Label Mix-Up

Product Description

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

Distribution Pattern

Nationwide within the United States

Other Recalls by AvKARE

Class II: Risk 12/31/2025

Out of specification for dissolution.
Class II: Risk 09/02/2025

Failed Content Uniformity Specifications
Class II: Risk 08/25/2025

Presence of a foreign substance.
Class II: Risk 08/25/2025

Presence of a foreign substance.
Class III: Low Risk 06/26/2025

Failed Impurity/Degradation Specifications

View all recalls by AvKARE →

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.