AvKARE: Drug Recall
Recall #D-0104-2025 · 10/18/2024
Class II: Risk
Recall Details
- Recall Number
- D-0104-2025
- 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
- 20 bottles
Reason for Recall
Labeling: Label Mix-Up
Product Description
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Distribution Pattern
Nationwide within the United States
Other Recalls by AvKARE
- Class II: Risk 12/31/2025
- Class II: Risk 09/02/2025
- Class II: Risk 08/25/2025
- Class II: Risk 08/25/2025
- Class III: Low Risk 06/26/2025
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.