Udenyca Recalled

On Feb. 26, 2026, the FDA issued a class I recall for multiple lots of Accord BioPharma’s Udenyca® (pegfilgrastim cbqv) injection, 6mg/0.6mL single dose prefilled syringes. The recall applies to 116 cartons that was prompted by temperature abuse, as the affected units were stored at controlled room temperature rather than the required refrigerated conditions, which may result in reduced product potency. Loss of potency in pegfilgrastim products is considered medically significant, as it may increase the risk of severe neutropenia and febrile neutropenia, potentially leading to serious infections, hospitalization or death in vulnerable patients. Udenyca is a leukocyte growth factor FDA approved biosimilar to Neulasta® (pegfilgrastim - Amgen) and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia in patients with non myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant risk of febrile neutropenia. It is also approved for increasing survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome). For more information about the recall, see here.