Class II
Drug Recall: 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.
ASTRAZENECA PHARMACEUTICALS · October 8, 2025
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
Nationwide in the U.S
States Affected
NATIONWIDE
Quantity Affected
916 pre-filled syringes
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0028-2026
Status: ongoing
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