Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Lot / code: Lot #: C274-000044756, C274-000044757, Exp 8-30-2025; C274-000044832, C274-000044833, Exp 9-4-2025; C274-000044882, C274-000044883, Exp 9-6-2025, C274-000044972, Exp 9-8-2025; C274-000045004, C274-000045005, Exp 9-18-2025 C274-000045108, exp. date 9-13-2025 C274-000045109, exp. date 9-13-2025 C274-000045136, exp. date 9-14-2025 C274-000045137, exp. date 9-14-2025 C274-000045289, exp. date 9-20-2025 C274-000045290, exp. date 9-20-2025 C274-000045350, exp. date 9-22-2025 C274-000045351, exp. date 9-22-2025 C274-000045387, exp. date 9-25-2025 C274-000045388, exp. date 9-25-2025 C274-000045516, exp. date 9-27-2025 C274-000045517, exp. date 9-27-2025 C274-000045586, exp. date 10-2-2025 C274-000045587, exp. date 10-2-2025 C274-000045676, exp. date 10-4-2025 C274-000045677, exp. date 10-4-2025 C274-000045707, exp. date 10-5-2025 C274-000045708, exp. date 10-5-2025 C274-000045754, exp. date 10-9-2025 C274-000045755, exp. date 10-9-2025 C274-000045840, exp. date 10-11-2025 C274-000045841, exp. date 10-11-2025 C274-000046048, exp. date 10-24-2025 C274-000046049, exp. date 10-24-2025 C274-000046095, exp. date 10-25-2025 C274-000046096, exp. date 10-25-2025 C274-000046122, exp. date 10-26-2025 C274-000046123, exp. date 10-26-2025 C274-000046164, exp. date 10-30-2025 C274-000046165, exp. date 10-30-2025 C274-000046191, exp. date 10-31-2025 C274-000046192, exp. date 10-31-2025 C274-000046240, exp. date 11-1-2025 C274-000046241, exp. date 11-1-2025 C274-000046315, exp. date 11-6-2025 C274-000046316, exp. date 11-6-2025 C274-000046345, exp. date 11-7-2025 C274-000046346, exp. date 11-7-2025 C274-000046515, exp. date 11-14-2025 C274-000046516, exp. date 11-14-2025 C274-000046603, exp. date 11-16-2025 C274-000046657, exp. date 11-20-2025 C274-000047136, exp. date 12-12-2025
Quantity: 109,320 syringes
Reason for recall
Lack of Assurance of Sterility
Recall record
Recall number
D-0646-2025
Classification
Class II
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
USA nationwide.
Recall initiated
2025-08-29
Classified by FDA Center
2025-09-12
FDA published
2025-09-24
Recalling firm
Fagron Compounding Services
Firm location
Wichita, KS
Operational response
Class II recalls indicate possible temporary or reversible health
consequences. Remove affected lots from active dispensing. Segregate
inventory. Check the firm’s recall notification for guidance on
patient outreach.