HIGH

Fasenra Benralizumab Injection Recall: 916 Pre-Filled Syringes Over Sterility Concern (2025)

AstraZeneca recalls 916 Fasenra benralizumab injections distributed nationwide in the United States. The lot is YJ0152 and the NDC is 0310-1730-30. The product is being recalled for lack of sterility assurance. Stop using this product immediately and contact AstraZeneca for guidance.

Quick Facts at a Glance

Recall Date
October 8, 2025
Hazard Level
HIGH
Brands
Fasenra, AstraZeneca
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

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

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About This Product

Fasenra is a prescription monoclonal antibody used to treat eosinophilic asthma. It is administered by healthcare professionals via injection.

Why This Is Dangerous

Lack of sterility assurance means the syringe could be contaminated, posing a risk of infection to patients.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

The 916 syringes in Lot YJ0152 are distributed nationwide. Immediate cessation of use is required to avoid potential infection and supply disruption for patients relying on this therapy.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 0310-1730-30 on the syringe label
  2. Check Lot number YJ0152 on the packaging
  3. Verify product is Fasenra 30 mg/mL in a single-dose pre-filled syringe

Where to find product info

Recall notice email from AstraZeneca and FDA recall page D-0028-2026

What timeline to expect

No timeline is provided for replacement or resolution in the notice

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to FDA Consumer Product Safety Commission or state health department if the company is unresponsive
  • Consider seeking medical guidance from a healthcare provider while waiting for resolution

How to prevent similar issues

  • Verify lot and NDC before administration of any biologic injection
  • Know recall contact channels and keep email notifications
  • Use official recall notices for guidance when handling biologic medications

Documentation advice

Keep copies of the recall notice, all correspondence with AstraZeneca, and the packaging/labels showing NDC and lot numbers

Product Details

NDC 0310-1730-30; Lot YJ0152; Quantity 916; Distribution Nationwide in the U.S.; Manufactured by AstraZeneca AB, Sweden; Distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 916 units recalled
  • NDC 0310-1730-30
  • Lot YJ0152
  • Nationwide distribution in the U.S.
  • Immediate action required
  • Recall notification by email

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERALPREGNANTPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
Lot YJ0152
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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