FDAClass I · Drug · Recalled June 17, 2026

DOXOrubin Hydrochloride Liposome injection recall — SUN PHARMACEUTICAL INDUSTRIES INC

Hazard: Presence of Particulate matter: Particulate matter identified as glass.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0580-2026
Brand: SUN PHARMACEUTICAL INDUSTRIES
Classification: Class I
Units affected: 675 vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

DOXOrubin Hydrochloride Liposome injection

Companies & origin

Recalling firm location: Princeton, NJ, United States
Firm address: 2 Independence Way, N/A, 08540-6620

Identifying details (verbatim from the notice)

Product codes / lots: Lot HAG2581B, expires: 05/31/2027
Distribution: U.S. Nationwide
Firm notified the public via: E-Mail
FDA event ID: 98921
Recall initiated: May 12, 2026
FDA classified: June 5, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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