FDA Drug recall D-0028-2026
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distribut…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distribut… by Astrazeneca Pharmaceuticals, citing lack of Assurance of Sterility:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0028-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-08 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Astrazeneca Pharmaceuticals |
| Distribution | US |
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:
Identifiers
| ndc | 0310-1730-30 |
|---|---|
| ndc | 0310-1730-85 |
| ndc | 0310-1830-30 |
| ndc | 0310-1830-85 |
| ndc | 0310-1745-01 |
| ndc | 0310-1745-95 |
| code_info | Lot YJ0152, Expiry: 01/31/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0028-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.