CLASS I ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
DOXOrubin Hydrochloride Liposome injection, 50 mg recalled
SUN Pharmaceutical Industries is recalling DOXOrubin Hydrochloride Liposome injection, 50 mg/ (2mg/mL) single-dose vials, Sterile, distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0580-2026
- FDA event ID
- 98921
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- NorthStar RxLLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 May 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 12 May 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +24 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate matter: Particulate matter identified as glass.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate matter: Particulate matter identified as glass.
Which lots are affected?
Lot HAG2581B, expires: 05/31/2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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