CLASS II Drug recall · Reported 31 Jan 2018 · FDA Enforcement Report
DOXOrubicin Hydrochloride Liposome Injection, 20 mg recalled
Sun Pharmaceutical Industries is recalling DOXOrubicin Hydrochloride Liposome Injection, 20 mg/ (2 mg/mL) Single Use Vial, distributed nationwide in the US. The recall was initiated on 16 Jan 2018 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-0229-2018
- FDA event ID
- 78947
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2018
- FDA classified
- 19 Jan 2018
- Reported
- 31 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Jan 2018 | Recall initiated by company | |
| 19 Jan 2018 | Classified by FDA | +3 days |
| 31 Jan 2018 | 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
Lack Of Assurance Of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
Where it was distributed
Product was distributed nationwide in the USA
Questions about this recall
Why was it recalled?
Lack Of Assurance Of Sterility
Which lots are affected?
Lot # JKS0403A Exp 02/2019
Where was it sold?
Product was distributed 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.
More recalls from Sun Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | 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 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 III | DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled | Mylan Institutional | Packaging Defects | Nationwide |