Doxorubicin Hydrochloride Liposome Injections Recalled Due to Foreign Contamination

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for doxorubicin hydrochloride liposome injection, 50 mg/25 mL. The affected batch has been identified as Lot HAG2581B (expires May 2027), affecting 675 vials.
• The recall was initiated by Sun Pharmaceutical Industries due to the presence of particulate matter, a quality issue that is likely to cause serious adverse health consequences or death.
• Doxorubicin hydrochloride liposome is used to treat ovarian cancer, AIDS-related Kaposi sarcoma, and multiple myeloma.

The FDA has issued a Class I recall for doxorubicin hydrochloride liposome injection, 50 mg/25 mL, affecting 675 vials. This medication is manufactured by Sun Pharmaceutical Industries in India. The recall was initiated by the branch in Princeton, New Jersey on May 12, 2026, and received a Class I classification on June 5, 2026. A Class I classification means the use of this product may cause serious adverse health consequences or death.

The recall was initiated due to the presence of glass particulates in the product. This deficiency affects Lot HAG2581B, which will expire in May 2027. Sun Pharmaceutical sent out a public notice via email and issued a press release on May 13, 2026.

Doxorubicin hydrochloride liposome is a prescription medication used to treat ovarian cancer and AIDS-related Kaposi sarcoma. It can also be combined with bortezomib to treat multiple myeloma. Pharmacists should identify and quarantine Lot HAG2581B, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 17, 2026. Accessed June 17, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220205