FDA-PR2026-05-13PACKAGING DEFECT

Aisling DOXOrubicin Hydrochloride Liposome Injection recalled for potential glass particles

GLASS
Nationwide distribution

Stop using affected DOXOrubicin Hydrochloride batch HAG2581B

Sun Pharmaceutical is recalling one batch (HAG2581B, expires 05/31/2027) of Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL because glass particles were detected in some vials during production. If injected, glass particles could cause local irritation, blood vessel blockage, or blood clots. No injuries have been reported so far.

  • If you work in a hospital or pharmacy: stop using batch HAG2581B and return vials to your supplier or discard per protocol
  • Check your inventory for NDC 72603-200-01, Lot# HAG2581B, Expiration 05/31/2027
  • If a patient received this batch, contact their physician or healthcare provider immediately
  • Report any adverse events to NorthStar Rx LLC at 1-800-206-7821 or FDA MedWatch at 1-800-332-1088

Product photos

Label, Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Label, Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
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

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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