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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

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 is being recalled due to the detection of glass particles in some vials during production.

If glass particles are administered intravenously, they may pose a risk to patient safety including local irritation or swelling in response to the foreign material. More serious potential risks could include blockage of blood vessels and life-threatening blood clot events. To date, Sun Pharma has not received any reports of adverse events related to this batch. Sun Pharma has thoroughly investigated the source of the problem and has taken corrective and preventative actions.

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