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Home › FDA recalls › DOXOrubin Hydrochloride Liposome injection
CLASS I · SeriousFDA

SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection

📅 May 12, 2026 · 📍 Nationwide
Recalling company
SUN PHARMACEUTICAL INDUSTRIES INC
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.
Reason
Presence of Particulate matter: Particulate matter identified as glass.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
May 12, 2026
Reported
Jun 17, 2026
Distribution
U.S. Nationwide
Status
Ongoing
Quantity
675 vials
Lot / codes
Lot HAG2581B, expires: 05/31/2027
Company location
Princeton, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0580-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0580-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.