Fasenra Injection, Solution
FDA Recall NDC 0310-1830

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Fasenra (NDC 0310-1830). A significant event, classified as Class II, was initiated on Oct 08, 2025 by Astrazeneca Pharmaceuticals Lp. The reported reason for this action was: "Lack of Assurance of Sterility:"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0028-2026ONGOING

October 2025 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0028-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility:
Initiated
Oct 08, 2025
Reported
Oct 22, 2025
Quantity
916 pre-filled syringes

Recall Profile & Regulatory Data

Event ID
97760
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ASTRAZENECA PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
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
Batch or Lot Expiration Information
Lot# Lot YJ0152, Expiry: 01/31/2028.
Affected Packages Involved in this Recall
0310-1730-30Product
0310-1730-85Product
0310-1830-30Product
0310-1830-85Product
0310-1745-01Product
0310-1745-95Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.