Recall archive / FDA company announcement

Aisling: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL — FDA announcement May 13, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date May 13, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Reason: Presence of glass particles
Classification: Not supplied
Recalling firm: Sun Pharmaceutical Industries, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 3187d30bdb6dd2df

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

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Distribution

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Dates in the source

Fda listing date: May 13, 2026
Company announcement date: May 13, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.