Sunitinib Malate Capsules — Class II drug recall D-0913-2023
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2023-07-19, distributed nationwide. Failed Moisture Limits: Water (moisture) content above the approved product specifications.
| Recall number | D-0913-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2023-07-05 |
| Classified | 2023-07-11 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 180 bottles |
| NDC | 00093-8199, 00093-8199-28, 00093-8224, 00093-8224-28, 00093-8229, 00093-8229-28, 00093-8231, 00093-8231-28 |
| Lot numbers | 100037220 |
| Expiration dates | 2024-10 |
Product
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Reason for recall
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
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-0913-2023. 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.