Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufact...
FDA Recall #D-0028-2026 — Class II — October 8, 2025
Product Description
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30
Reason for Recall
Lack of Assurance of Sterility:
Recalling Firm
ASTRAZENECA PHARMACEUTICALS — Gaithersburg, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
916 pre-filled syringes
Distribution
Nationwide in the U.S
Code Information
Lot YJ0152, Expiry: 01/31/2028.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated