HIGH

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....

Lack of Assurance of Sterility:

Quick Facts at a Glance

Recall Date
October 8, 2025
Hazard Level
HIGH
Brands
FASENRA, AstraZeneca Pharmaceuticals LP
Geographic Scope
1 states

Hazard Information

Lack of Assurance of Sterility:

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ASTRAZENECA PHARMACEUTICALS or your healthcare provider for guidance. Notification method: E-Mail

Full 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. Generic: BENRALIZUMAB; Brand: FASENRA. Reason: Lack of Assurance of Sterility:. Classification: Class II. Quantity: 916 pre-filled syringes. Distribution: Nationwide in the U.S

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot YJ0152
Expiry: 01/31/2028.
UPC Codes
0310-1730
0310-1830
0310-1745
+6 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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