Chemotherapy Tablets Recalled

Three lots of Votrient distributed throughout the United States by Novartis Pharmaceuticals Corporation are being recalled because samples of the drug failed to meet dissolution specifications, according to the December 20, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Votrient (pazopanib) tablets, 200 mg, in 120-count bottles (NDC 0078-1077-66) from lots ME2713 (Exp. 2/25), MF8286 (Exp. 4/25), and ML1860 (Exp. 4/25). The tablets were manufactured by Siegried Barbera SL, Barbera del Valles, Spain.

Siegried Barbera SL voluntarily initiated the recall November 20, 2023. On December 13, 2023, the FDA designated the recall Class III, suggesting use of the recalled tablets is not likely to cause harm.

Votrient is a prescription medication indicated for the treatment of adults with advanced renal cell carcinoma and adults with advanced soft tissue sarcoma who have received prior chemotherapy.