FDA Announces Class II Recall of Bevacizumab Injection

The US Food and Drug Administration (FDA) has announced a nationwide Class II recall of bevacizumab (Avastin) Injection, 1.25mg/0.05mL, packaged in sterile single-dose syringes by Fagron Sterile Services, based in Wichita, Kansas. The recall affects over 109 000 syringes distributed across the United States. The impacted products include multiple lot numbers with expiration dates ranging from August 30, 2025, to September 18, 2025. The recall was voluntarily initiated by the firm on August 29, 2025, and remains ongoing.

The reason cited for the recall is a lack of assurance of sterility. In sterile injectable products, this poses a significant safety concern because contamination could lead to serious infections or other adverse patient outcomes. While no public press release has been issued, notifications have been sent to consignees via letter. The FDA formally classified the recall as Class II on September 12, 2025, meaning use of the product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is considered remote.

Bevacizumab, marketed under the brand name Avastin, is a monoclonal antibody used to inhibit angiogenesis by targeting vascular endothelial growth factor (VEGF). Clinically, it is indicated in oncology for various cancers including colorectal, lung, and renal cancers, and is also used in ophthalmology for off-label treatment of retinal conditions such as age-related macular degeneration. Pharmacists should remain vigilant for the affected lot numbers and ensure recalled inventory is properly segregated to prevent patient exposure.