CLASS II Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Doxil (doxorubicin hydrochloride liposome injection) 50 mg recalled
Baxter Healthcare is recalling Doxil (doxorubicin hydrochloride liposome injection) 50 mg in (2 mg/mL), Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 24 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0048-2024
- FDA event ID
- 93201
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Doxil
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2023
- FDA classified
- 17 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Aug 2023 | Recall initiated by company | |
| 17 Oct 2023 | Classified by FDA | +54 days |
| 25 Oct 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Which lots are affected?
Lot# MKZSU02, Exp 6/30/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Doxorubicin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | DOXOrubicin Hydrochloride Injection, USP, 10 mg recalledDoxorubicin Hydrochloride | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS II | Doxorubicin 110 MG / IVP Syringe recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | DOXOrubicin Hydrochloride Liposome Injection, 20 mg recalledDoxorubicin Hydrochloride | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS III | DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled | Mylan Institutional | Packaging Defects | Nationwide |