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Class I · Most seriousActive recall

Doxorubicin Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot HAG2581B, expires: 05/31/2027
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate matter: Particulate matter identified as glass.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India foreign manufacturer
Brand nameDOXORUBICIN HYDROCHLORIDE
Generic nameDOXORUBICIN HYDROCHLORIDE
Active ingredient(s)DOXORUBICIN HYDROCHLORIDE
Distributed by / forNorthstar Rx LLC., Memphis, TN 38141
NDC72603-200-01
Show the full FDA record
Full product labelDOXOrubin 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 firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionU.S. Nationwide
Quantity675 vials
Recall initiated2026-05-12
Report date2026-06-17
Recall completed—
Recall numberD-0580-2026
ClassificationClass I
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.