Skip to content
Back to recalls
Drug FDA Class II Ongoing Contamination / non-sterility

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

ASTRAZENECA PHARMACEUTICALS Published Oct 22, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact ASTRAZENECA PHARMACEUTICALS or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility:

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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

FASENRA · 916 pre-filled syringes

NDC: 0310-1730, 0310-1830, 0310-1745, 0310-1730-30, 0310-1730-85, 0310-1830-30, 0310-1830-85, 0310-1745-01, 0310-1745-95
Lot codes: YJ0152
Code info: Lot YJ0152, Expiry: 01/31/2028.

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 8, 2025
  2. Published
    Oct 22, 2025
Recall number
D-0028-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.