Benralizumab Recall: Fasenra 30 mg/mL pre-filled syringe
Announced 2025-10-22 · FDA
The FDA is recalling 916 pre-filled syringes of Fasenra (benralizumab) due to lack of assurance of sterility. The affected lot is YJ0152, expiring 01/31/2028, distributed nationwide in the U.S. No corrective action is listed.
| Brand | ASTRAZENECA PHARMACEUTICALS |
|---|---|
| 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 |
| Reason | Lack of Assurance of Sterility: |
| Severity | moderate |
| Units affected | 916 |
| Distribution | Nationwide in the U.S |
| Agency | FDA |
| Recall / campaign no. | Lot YJ0152, Expiry: 01/31/2028. |
WHAT YOU SHOULD DO
- Do not use any recalled Fasenra pre-filled syringes from Lot YJ0152.
- Return the recalled syringes to your healthcare provider or pharmacy for disposal or replacement.
- If you are currently receiving treatment, contact your healthcare provider for guidance on alternatives or replacement.
- Monitor for updates from the FDA or your healthcare provider regarding the recall.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.