FDA recall D-0028-2026

ASTRAZENECA PHARMACEUTICALS · Class II · drug

Product

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:

Distribution

Nationwide in the U.S

Key facts

Status: Ongoing
Initiation date: 2025-10-08
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2026