Sun Pharma recalled 675 vials of doxorubicin hydrochloride liposome, a chemotherapy drug for AIDS-related Kaposi sarcoma, multiple myeloma, and ovarian cancer, after detecting glass particles in some vials. Intravenous dosing of the contaminated product can cause local irritation, blood vessel blockages, and life-threatening blood clots. No adverse events have been reported.
The vials were manufactured at Sun’s facility in Halol, India, a site with compliance problems stretching back more than 10 years. FDA inspectors found 19 pages of problems there in 2014. The agency sent a warning letter the following year and rescinded approval of Sun’s epilepsy drug Elepsia XR. A 2016 inspection triggered a Form 483 with nine observations. FDA rejected Elepsia XR again in 2017, citing inspection findings.
Sun resolved those warning letter issues by 2018, but the problems didn’t stop. FDA issued another Form 483 in 2019, then classified Halol as “official action indicated” in 2020. A 2022 inspection led to a second warning letter: inspectors found Sun’s vial-filling equipment caused friction that introduced “blackish fine metallic particles.” FDA imposed an import alert on Halol-made goods.
FDA inspectors returned in 2025, issuing a Form 483 in June. In September, the agency classified Halol as OAI again. Sun says it’s taken “corrective and preventive actions” but hasn’t disclosed details.
Organizations holding affected vials should stop use and return them to their place of purchase.
Sarah Chen