Class IOngoing

DOXOrubin Hydrochloride Liposome injection recall

FDA recall D-0580-2026 · initiated May 12, 2026

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

Presence of Particulate matter: Particulate matter identified as glass.

Details

Product: 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.
Recalling company: Sun Pharm Industries
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: May 12, 2026
FDA report date: Jun 17, 2026

This recall is linked to a product we cover: Doxorubicin Hydrochloride (Liposomal) →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0580-2026 ↗

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