FDAHealthOctober 8, 2025
ASTRAZENECA PHARMACEUTICALS — Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceutic
⚠️ Lack of Assurance of Sterility:
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 8, 2025
Nationwide in the U.S
What's affected?
- 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
- Brand
- FASENRA
- Lot code
- YJ0152
Additional details
Lot YJ0152, Expiry: 01/31/2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 916 pre-filled syringes.
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