Doxorubicin Hydrochloride Injectable, Liposomal
FDA Recall NDC 72603-200
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxorubicin Hydrochloride (NDC 72603-200). A significant event, classified as Class I, was initiated on May 12, 2026 by Northstar Rxllc. The reported reason for this action was: "Presence of Particulate matter: Particulate matter identified as glass."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate matter: Particulate matter identified as glass.
May 12, 2026
Jun 17, 2026
675 vials
Recall Profile & Regulatory Data
Event ID
98921
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot HAG2581B, expires: 05/31/2027
Affected Packages Involved in this Recall
72603-103-01Product
72603-200-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
