DOXORUBICIN HYDROCHLORIDE
Recalling Firm / Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
(Princeton, NJ, United States)
FDA Recall Number: D-0580-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
DOXORUBICIN HYDROCHLORIDE
Generic Name
DOXORUBICIN HYDROCHLORIDE
Active Substance(s)
Doxorubicin Hydrochloride
Administration Route
Intravenous
National Drug Code (NDC)
72603-103
Total Quantity Recalled
675 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Particulate matter: Particulate matter identified as glass.
Full Product Description
Packaging specifications and labeling details
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
June 17, 2026
Firm Initiation Date
May 12, 2026
FDA Classification Date
Jun 05, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot HAG2581B, expires: 05/31/2027
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0580-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508602UTCC