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Class I: serious health riskOngoing

Sun Pharmaceutical Industries DOXOrubin Hydrochloride Liposome injection Recall

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose via…

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Risk level
Class I
Reported by FDA
Jun 17, 2026
Recall ID
D-0580-2026
Check your lot numberHow we source this data

Summary

Sun Pharmaceutical Industries recalled DOXOrubin Hydrochloride Liposome injection starting May 12, 2026. The FDA classified it as Class I (serious health risk) and published enforcement report D-0580-2026 on Jun 17, 2026. Reason: Presence of Particulate matter: Particulate matter identified as glass. Status: Ongoing.

Why it was recalled

Presence of Particulate matter: Particulate matter identified as glass.

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.

Lot numbers, UPCs & expiration codes

Lot HAG2581B, expires: 05/31/2027

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0580-2026
Classification
Class I
Status
Ongoing
Recall initiated
May 12, 2026
FDA report date
Jun 17, 2026
Quantity
675 vials
Recall type
Voluntary: Firm initiated
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC

Original FDA data

Every field from FDA enforcement report D-0580-2026, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Ongoing
Country
United States
Event ID
98921
Address
2 Independence Way
Code information
Lot HAG2581B, expires: 05/31/2027
Postal code
08540-6620
Report date
Jun 17, 2026
Product type
Drugs
Recall number
D-0580-2026
Classification
Class I
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product quantity
675 vials
Reason for recall
Presence of Particulate matter: Particulate matter identified as glass.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
U.S. Nationwide
Recall initiation date
May 12, 2026
Initial firm notification
E-Mail
Center classification date
Jun 5, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0580-2026, published Jun 17, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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