Class III · Low risk
DOXOrubicin Hydrochloride Injection
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Doxil (doxorubicin hydrochloride liposome injection)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDC
0338-0067-01
Compare with the code on your package — it is the most precise check available.
Drug: Doxorubicin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Doxil doxorubicin hydrochloride NDC 00338-0067 |
2 mg/mL | Injection, Suspension, Liposomal Intravitreal |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 0338-0067-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0048-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Doxorubicin recalls
See all
Class II · Moderate risk
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Doxorubicin 110 MG / 55 ML IVP SYRINGE
Lack of Assurance of Sterility
Class II · Moderate risk
DOXOrubicin Hydrochloride Liposome Injection
Lack Of Assurance Of Sterility
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Other recalls by Baxter Healthcare Corporation
All 2023 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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