Astrazeneca Pharmaceuticals Fasenra Injection Recall (Class II)

Why it was recalled

Lack of Assurance of Sterility:

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

Lot numbers, UPCs & expiration codes

Lot YJ0152, Expiry: 01/31/2028.

Where it was sold

Nationwide in the U.S

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0028-2026
Classification: Class II
Status: Ongoing
Recall initiated: Oct 8, 2025
FDA report date: Oct 22, 2025
Quantity: 916 pre-filled syringes
Recall type: Voluntary: Firm initiated
Recalling firm: ASTRAZENECA PHARMACEUTICALS

Original FDA data

Every field from FDA enforcement report D-0028-2026, exactly as published.

Show all FDA fields

City: Gaithersburg
State: MD
Status: Ongoing
Country: United States
Event ID: 97760
Address: 950 Wind River Ln
Code information: Lot YJ0152, Expiry: 01/31/2028.
Postal code: 20878-1974
Report date: Oct 22, 2025
Product type: Drugs
Recall number: D-0028-2026
Classification: Class II
Recalling firm: ASTRAZENECA PHARMACEUTICALS
Product quantity: 916 pre-filled syringes
Reason for recall: Lack of Assurance of Sterility:
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide in the U.S
Recall initiation date: Oct 8, 2025
Initial firm notification: E-Mail
Center classification date: Oct 16, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0028-2026, published Oct 22, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Astrazeneca Pharmaceuticals Fasenra Recall

Summary