FDA Recall D-0104-2025
AvKARE · Pulaski, TN
Class II Ongoing 573 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Reason for recall
Labeling: Label Mix-Up
Recall record
- Recall number
D-0104-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-10-18
- Classified by FDA Center
- 2024-12-04
- FDA published
- 2024-12-11
- Recalling firm
- AvKARE
- Firm location
- Pulaski, TN
Drug identification
- Brand name(s)
- SUNITINIB MALATE
- Generic name(s)
- SUNITINIB MALATE
- Manufacturer(s)
- AvKARE
- NDC(s)
42291-901, 42291-902, 42291-903, 42291-904- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.