CLASS III Drug recall · Reported 25 Mar 2015 · FDA Enforcement Report
DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled
Mylan Institutional is recalling DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL), For IV Use Only, Sterile, distributed nationwide in the US. The recall was initiated on 11 Feb 2015 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-0412-2015
- FDA event ID
- 70565
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Feb 2015
- FDA classified
- 13 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Feb 2015 | Recall initiated by company | |
| 13 Mar 2015 | Classified by FDA | +30 days |
| 25 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot Number: 7801009; Exp: Apr-2015
Where was it sold?
Nationwide
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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | 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 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 |