Fasenra — Class II drug recall D-0028-2026
Ongoing recall by ASTRAZENECA PHARMACEUTICALS, reported 2025-10-22, distributed nationwide. Lack of Assurance of Sterility:
| Recall number | D-0028-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ASTRAZENECA PHARMACEUTICALS, Gaithersburg, MD, United States |
| Recall initiated | 2025-10-08 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 916 pre |
| Reason classes | sterility |
| NDC | 00310-1730, 00310-1730-30, 00310-1730-85, 00310-1745, 00310-1745-01, 00310-1745-95, 00310-1830, 00310-1830-30, 00310-1830-85 |
| Lot numbers | YJ0152 |
| Expiration dates | 2028-01-31 |
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 for recall
Lack of Assurance of Sterility:
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0028-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.