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Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome ...
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA
About this update from Sun Pharmaceutical Industries Limited
[{"type":"text","content":" COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos Summary Company Announcement Date: May 13, 2026 FDA Publish Date: May 13, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of glass particles Company Name: Sun Pharmaceutical Industries, Inc. Brand Name: Product Description: Product Description DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Company Announcement 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. Doxorubicin Hydrochloride Liposome Injection is indicated for Ovarian cancer, AIDS Related Kaposi Sarcoma and Multiple Myeloma. The product is packaged in translucent, red liposomal dispersion in 25 mL glass, single-dose vials for NDC 72603-200-01. The affected DOXOrubicin Hydrochloride Liposome Injection batch is Batch HAG2581B, Expiration 05/31/2027. The product can be identified by the label (Aisling Label), each vial is labeled to indicate the name of the product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, NDC 72603-200-01 Lot# HAG2581B, Expiration 05/31/2027. Sun Pharma is notifying its distributor and customers by express overnight mail and is arranging for return/replacement etc. of all recalled products. Distributors/retailers/hospitals/users that have the product should stop using and return to place of purchase or discard the product. Consumers should cont...