Doxil — Class II drug recall D-0048-2024
Terminated recall by Baxter Healthcare Corporation, reported 2023-10-25, distributed nationwide. CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transport
| Recall number | D-0048-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-08-24 |
| Classified | 2023-10-17 |
| Reported by FDA | 2023-10-25 |
| Terminated | 2025-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 472 vials |
| Reason classes | labeling, cgmp |
| NDC | 00338-0063, 00338-0063-01, 00338-0067, 00338-0067-01 |
| Lot numbers | MKZSU02 |
| Expiration dates | 2024-06-30 |
Product
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
Reason for recall
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
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-0048-2024. 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.