US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 8, 2025 (11 months ago)

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility:

What was recalled

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

Recalling firm
Astrazeneca Pharmaceuticals
NDC code
0310-1730-30
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0028-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.