CLASS III Drug recall · Reported 2 Dec 2020 · FDA Enforcement Report
DOXOrubicin Hydrochloride Injection, USP, 10 mg recalled
Fresenius Kabi USA is recalling DOXOrubicin Hydrochloride Injection, USP, 10 mg / (2 mg / mL) fill in a vial, Single Dose, distributed nationwide in the US. The recall was initiated on 17 Nov 2020 and the FDA has classified it as Class III.
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-0105-2021
- FDA event ID
- 86765
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Nov 2020
- FDA classified
- 24 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Nov 2020 | Recall initiated by company | |
| 24 Nov 2020 | Classified by FDA | +7 days |
| 2 Dec 2020 | 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
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Product as listed by the FDA
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Which lots are affected?
Batch: 6120525, exp 11/2020
Where was it sold?
Nationwide USA and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
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 II | Doxil (doxorubicin hydrochloride liposome injection) 50 mg recalledDoxil | Baxter Healthcare | Manufacturing (CGMP) Deviations | 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 |