Fasenra Injection recalled over sterility concerns

Recall date

October 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ASTRAZENECA PHARMACEUTICALS recalls Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca A…

Recall number

D-0028-2026

FDA classification

Class II

Brand / firm

ASTRAZENECA PHARMACEUTICALS

Sold / distributed

Nationwide in the U.S

Why it was recalled

Lack of Assurance of Sterility:

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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