FDA-PR2026-05-13PACKAGING DEFECT

Sun Pharma Aisling doxorubicin injection recalled for glass particles in vials

GLASSNationwide distributionDrugs

What this means

Sun Pharmaceutical is recalling one batch of Aisling doxorubicin hydrochloride liposome injection (a cancer medication) because glass particles were found in some vials during manufacturing. Glass particles in injectable medications can cause local tissue damage, blood vessel blockage, or blood clots if injected into the bloodstream. No patient injuries have been reported so far.

  • If you are a hospital, pharmacy, or healthcare provider: stop using batch HAG2581B (expiration 05/31/2027) and return it or discard it safely.
  • If you have received this medication or used it: contact your doctor or healthcare provider immediately.
  • Report any problems or side effects to the FDA's MedWatch program at www.fda.gov/medwatch/report.htm or call 1-800-332-1088.
  • For recall questions, contact the recall processor Inmar Inc. at 855-745-9357 (Monday–Friday, 8:30 a.m.–5:00 p.m. ET) or rxrecalls@inmar.com.
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Product photos

Label, Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Label, Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
The agency's original wording
Hazard

FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials i

Intended for
Adults
Illnesses reported
None reported

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-sun-pharma-initiates-voluntary-us-nationwide-recall-doxorubicin

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