The Recall Desk
HighFDA (Drugs)·D-0646-2025·Announced 2025-09-24

Bevacizumab Injection Syringes Recalled for Sterility Assurance Concerns

Fagron Compounding Services is recalling 109,320 syringes of bevacizumab (Avastin) Injection due to lack of assurance of sterility. The product was distributed nationwide with multiple lot numbers and expiration dates through December 2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of sterile injectable medication due to lack of sterility assurance constitutes a risk-of-harm product. While no illnesses or injuries have been reported, sterility failures in injectable medications pose potential for serious infection. This fits the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Fagron Compounding Services is recalling approximately 109,320 sterile single-dose syringes of bevacizumab (Avastin) Injection, 1.25mg/0.05mL. The affected product was distributed nationwide with multiple lot numbers and expiration dates ranging from August 2025 through December 2025.

The FDA Class II recall was initiated due to lack of assurance of sterility in the affected syringes.

Patients and healthcare providers who have received or possess syringes from the affected lot numbers should consult their healthcare provider regarding this recall. Syringes from the affected lots should not be used.

The recalled product

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
Manufacturer
Fagron Compounding Services
Category
Drug — Injectable
Hazard
  • sterility-assurance
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category