D-0028-2026 Class II Ongoing
FDA drug recall D-0028-2026 was initiated by ASTRAZENECA PHARMACEUTICALS on October 8, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The recall status is ongoing. Affected quantity: 916 pre-filled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 22, 2025
- Initiation Date
- October 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 916 pre-filled syringes
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:
Distribution Pattern
Nationwide in the U.S
Code Information
Lot YJ0152, Expiry: 01/31/2028.