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FDA · DrugsClass I

Sun Pharmaceutical Industries Inc drug recall: DOXOrubin Hydrochloride Liposome injection

Foreign material

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Ongoing
Event ID
98921
Recall initiated
May 12, 2026
Classified by FDA
Jun 5, 2026
Posted in Enforcement Report
Jun 17, 2026
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Firm location
Princeton, NJ, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Presence of Particulate matter: Particulate matter identified as glass.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on May 12, 2026. FDA classified it 24 days later, on Jun 5, 2026. Distribution reported by FDA: U.S. Nationwide SUN PHARMACEUTICAL INDUSTRIES INC has 95 recalls in our records.

Recalled products (1)

  • D-0580-2026 Class I Ongoing

    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.

    Codes / lots: Lot HAG2581B, expires: 05/31/2027

    Quantity: 675 vials

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 98921
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.