FASENRA
Recalling Firm / Manufacturer: ASTRAZENECA PHARMACEUTICALS
(Gaithersburg, MD, United States)
FDA Recall Number: D-0028-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
FASENRA
Generic Name
BENRALIZUMAB
Active Substance(s)
Benralizumab
Administration Route
Subcutaneous
National Drug Code (NDC)
0310-1730
Total Quantity Recalled
916 pre-filled syringes
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Lack of Assurance of Sterility:
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 22, 2025
Firm Initiation Date
October 08, 2025
FDA Classification Date
Oct 16, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot YJ0152, Expiry: 01/31/2028.
Distribution Information
Geographic scope of affected shipments
Nationwide in the U.S
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0028-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC