Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles
Sun Pharmaceutical Industries, Inc. initiated a voluntary nationwide recall of one batch (Lot # HAG2581B, 675 vials) of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL due to potential glass particle contamination.
This recall affects Sun Pharma, hospital pharmacies, oncology departments, and healthcare providers utilizing this specific lot of DOXOrubicin Hydrochloride Liposome Injection.
The presence of glass particles in an injectable medication presents significant safety risks, including potential vascular injury, embolic events, or localized inflammation. From a regulatory perspective, this necessitates a thorough investigation into the container-closure integrity or manufacturing processes that may have introduced the particulates.
Pharmacy and clinical staff should immediately quarantine Lot # HAG2581B and cease administration. Quality units should review inspection and visual testing protocols for parenteral products to mitigate future risks of particulate contamination.
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
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