ASTRAZENECA PHARMACEUTICALS: Drug Recall

Recall #D-0028-2026 · 10/08/2025

Class II: Risk

Recall Details

Recall Number
D-0028-2026
Classification
Class II
Product Type
Drug
Recalling Firm
ASTRAZENECA PHARMACEUTICALS
Status
Ongoing
Date Initiated
10/08/2025
Location
Gaithersburg, MD, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
916 pre-filled syringes

Reason for Recall

Lack of Assurance of Sterility:

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

Distribution Pattern

Nationwide in the U.S

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.