Recalls / Class II
Class IID-0028-2026
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 name
- Fasenra
- Generic name
- Benralizumab
- Active ingredient
- Benralizumab
- Route
- Subcutaneous
- NDCs
- 0310-1730, 0310-1830, 0310-1745
- FDA application
- BLA761070
- Affected lot / code info
- Lot YJ0152, Expiry: 01/31/2028.
Why it was recalled
Lack of Assurance of Sterility:
Recalling firm
- Firm
- ASTRAZENECA PHARMACEUTICALS
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 950 Wind River Ln, Gaithersburg, Maryland 20878-1974
Distribution
- Quantity
- 916 pre-filled syringes
- Distribution pattern
- Nationwide in the U.S
Timeline
- Recall initiated
- 2025-10-08
- FDA classified
- 2025-10-16
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0028-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.