Class II · Moderate risk
Doxil (doxorubicin hydrochloride liposome injection)
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Is Doxorubicin recalled?
Not under an active recall.
Doxorubicin was recalled 8 times in the past — all now closed. Most recent: Aug 24, 2023.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Doxorubicin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Doxorubicin recalls on record
none so far in 2026; 8 on record, newest first
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Cross Contamination with Other Products: trace amounts of octreotide found during testing
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
Class II · Moderate risk
Doxorubicin HCI active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Doxorubicin HCL
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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