FDA Recall D-0028-2026
ASTRAZENECA PHARMACEUTICALS · Gaithersburg, MD
Class II Ongoing 218 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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:
Recall record
- Recall number
D-0028-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the U.S
- Recall initiated
- 2025-10-08
- Classified by FDA Center
- 2025-10-16
- FDA published
- 2025-10-22
- Recalling firm
- ASTRAZENECA PHARMACEUTICALS
- Firm location
- Gaithersburg, MD
Drug identification
- Brand name(s)
- FASENRA
- Generic name(s)
- BENRALIZUMAB
- Manufacturer(s)
- AstraZeneca Pharmaceuticals LP
- NDC(s)
0310-1730, 0310-1830, 0310-1745- Route(s)
- SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.