Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IDrug recallOngoing

DOXOrubin Hydrochloride Liposome injection recall

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, NJ · FDA report 06/17/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class I; Most serious
Status: Ongoing
Recall started: 05/12/2026
Distribution: Nationwide

Reason for recall

Presence of Particulate matter: Particulate matter identified as glass.

Class I: A reasonable chance that using or being exposed to the product will cause serious health problems or death.

Recalled product

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.
Lot and code info: Lot HAG2581B, expires: 05/31/2027
Quantity: 675 vials
Brand names: DOXORUBICIN HYDROCHLORIDE
Recall number: D-0580-2026
Event ID: 98921
Initiated by: Voluntary: Firm initiated

Where it was distributed

U.S. Nationwide

Nationwide

Recall timeline

05/12/2026Firm started the recall
06/05/2026FDA classified it as Class I
06/17/2026Published in the FDA enforcement report

More recalls from SUN PHARMACEUTICAL INDUSTRIES

Frequently asked questions

Why was DOXOrubin Hydrochloride Liposome injection recalled?: Presence of Particulate matter: Particulate matter identified as glass.
What does Class I mean?: Class I is FDA's most serious recall category: a reasonable chance that using or being exposed to the product will cause serious health problems or death.
Where was the recalled product sold?: U.S. Nationwide
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 06/17/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class I
Status: Ongoing
Type: Drug
Reported: 06/17/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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