FDA Drug recall D-0580-2026
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx…
- FDA Drug
- Class I
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class I recall of DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx… by Sun Pharmaceutical Industries, citing presence of Particulate matter: Particulate matter identified as glass.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0580-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Presence of Particulate matter: Particulate matter identified as glass.
Identifiers
| ndc | 72603-103-01 |
|---|---|
| ndc | 72603-200-01 |
| code_info | Lot HAG2581B, expires: 05/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0580-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.