Drug FDA Class I Ongoing Foreign material

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.

SUN PHARMACEUTICAL INDUSTRIES INC Published Jun 17, 2026

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of Particulate matter: Particulate matter identified as glass.

Hazards

Glass · primary

Affected products (1)

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.

DOXORUBICIN HYDROCHLORIDE · 675 vials

NDC: 72603-103, 72603-200, 72603-103-01, 72603-200-01

Lot codes: HAG2581B

Code info: Lot HAG2581B, expires: 05/31/2027

Affected areas

Nationwide

Timeline

Initiated

May 12, 2026
Published

Jun 17, 2026

Recall number: D-0580-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.