FDA Drug recall D-0048-2024
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthca…
- FDA Drug
- Class II
- terminated
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthca… by Baxter Healthcare, citing CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0048-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-24 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Identifiers
| ndc | 0338-0063-01 |
|---|---|
| ndc | 0338-0067-01 |
| code_info | Lot# MKZSU02, Exp 6/30/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0048-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.