Stop using nowDrug recall · FDA · Published May 12, 2026
Sun Pharmaceutical DOXOrubin Liposome Injection Recall: Glass Particulate Risk
Sun Pharmaceutical recalls DOXOrubin Hydrochloride Liposome injections due to glass particles. This may cause serious injury if injected. Affected lots: HAG2581B, expires 05/31/2027.
“Sun Pharmaceutical DOXOrubin Liposome Injection Recall: Glass Particulate Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31312-sun-pharmaceutical-doxorubin-liposome-injection-recall-glass-particulate-risk. Based on FDA recall #D-0580-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0580-2026%22&limit=1).
The FDA announced on May 12, 2026, that Sun Pharmaceutical is recalling DOXOrubin Hydrochloride Liposome injection due to the presence of glass particulate matter. The recall affects 675 vials distributed nationwide.
How to tell if you have it
Brand: Sun Pharmaceutical
Product: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials
NDC: 72603-200-01
Lot: HAG2581B
Expiration: 05/31/2027
The hazard
The recall is due to the presence of particulate matter identified as glass within the injection vials. The FDA classified this as a Class I recall, indicating a high risk of serious adverse health consequences.
Context
GovInfoNow's records show Sun Pharmaceutical has issued 93 other recalls since May 21, 2013. Recent brand recalls include a September 14, 2026, Nystatin Cream recall for failed stability specifications and an August 3, 2026, Carbamazepine Tablets recall for black spots from burnt ingredients. Other recent recalls of similar products include Sunny Pharmtech Cyclophosphamide Injection (July 17, 2026), Lupin Liraglutide Injection (April 24, 2026), and Imprimis Dexamethasone Moxifloxacin Eye Drops (December 18, 2025).
How to tell if you have this one
Check the lot number on the vial label, which should be HAG2581B. The product expires May 31, 2027, and is a 25 mL single-dose vial for prescription use.
Brand
Sun Pharmaceutical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled DOXOrubin Hydrochloride Liposome injection vials with lot number HAG2581B.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0580-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0580-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.