Sunitinib Malate Capsules — Class II drug recall D-0103-2025
Ongoing recall by AvKARE, reported 2024-12-11, distributed nationwide. Labeling: Label Mix-Up
| Recall number | D-0103-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2024-10-18 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 40 bottles |
| Reason classes | labeling |
| NDC | 42291-0901, 42291-0901-28, 42291-0902, 42291-0902-28, 42291-0903, 42291-0903-28, 42291-0904, 42291-0904-28 |
| Lot numbers | 100049371 |
| Expiration dates | 2026-07-31 |
Product
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Reason for recall
Labeling: Label Mix-Up
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0103-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.