FDA recall D-0580-2026

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.

Reason for recall

Presence of Particulate matter: Particulate matter identified as glass.

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-05-12

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0580-2026