Fasenra (benralizumab) Injection recall
FDA recall D-0028-2026 · initiated Oct 8, 2025
ASTRAZENECA PHARMACEUTICALS recalled Fasenra (benralizumab) Injection in Oct 2025 — an FDA Class II recall (D-0028-2026) because Lack of Assurance of Sterility:.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility:
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 916 pre-filled syringes
Details
- Product
- 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
- Recalling company
- Astrazeneca
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S
- Initiated
- Oct 8, 2025
- FDA report date
- Oct 22, 2025
This recall is linked to a product we cover: Fasenra →
Frequently asked
- Was Fasenra (benralizumab) Injection recalled?
- ASTRAZENECA PHARMACEUTICALS recalled Fasenra (benralizumab) Injection in Oct 2025 — an FDA Class II recall (D-0028-2026) because Lack of Assurance of Sterility:. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fasenra (benralizumab) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0028-2026 was: Lack of Assurance of Sterility:
- Is a recalled Fasenra (benralizumab) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fasenra (benralizumab) Injection are affected?
- Distributed: Nationwide in the U.S. The recall covers these lots — Lot YJ0152, Expiry: 01/31/2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0028-2026.