DOXOrubin Hydrochloride Liposome injection — Class I drug recall D-0580-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-06-17, distributed nationwide. Presence of Particulate matter: Particulate matter identified as glass.
| Recall number | D-0580-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 675 vials |
| Reason classes | foreign material, specification failure |
| NDC | 72603-0103, 72603-0103-01, 72603-0200, 72603-0200-01 |
| Lot numbers | HAG2581B |
| Expiration dates | 2027-05-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0580-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.