HIGH

AstraZeneca Recalls Fasenra Injection Due to Sterility Concerns

AstraZeneca recalled 916 pre-filled syringes of Fasenra on October 8, 2025. The recall follows a lack of assurance of sterility, posing serious health risks. Consumers and healthcare providers must stop using the product immediately.

Quick Facts at a Glance

Recall Date
October 8, 2025
Hazard Level
HIGH
Brands
FASENRA, AstraZeneca Pharmaceuticals LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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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Product Details

Fasenra (benralizumab) Injection, 30 mg/mL, is a prescription-only product. It is packaged in single-dose pre-filled syringes with NDC 0310-1730-30. The recalled product includes Lot YJ0152, which expires on January 31, 2028.

The Hazard

The recall stems from a lack of assurance of sterility, which can lead to serious infections. This issue is classified as Class II by the FDA, indicating a high level of risk.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. However, the potential for serious health consequences remains a concern.

What to Do

Stop using the recalled product immediately. Contact AstraZeneca Pharmaceuticals or your healthcare provider for guidance. Consumers can notify AstraZeneca via email.

Contact Information

For more information, visit the AstraZeneca website or contact their customer service directly. Additional details can be found at the FDA recall notification page.

Key Facts

  • Recalled product: Fasenra Injection
  • Manufacturer: AstraZeneca AB, Sweden
  • Distribution: Nationwide in the U.S
  • Quantity recalled: 916 pre-filled syringes
  • Recall date: October 8, 2025

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

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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