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
Reported: October 22, 2025 Initiated: October 8, 2025 #D-0028-2026
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
Reason for Recall
Lack of Assurance of Sterility:
Details
- Recalling Firm
- ASTRAZENECA PHARMACEUTICALS
- Units Affected
- 916 pre-filled syringes
- Distribution
- Nationwide in the U.S
- Location
- Gaithersburg, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ASTRAZENECA PHARMACEUTICALS. Units affected: 916 pre-filled syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 22, 2025. Severity: Moderate. Recall number: D-0028-2026.
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