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D-0028-2026 Class II Ongoing

Recalled by ASTRAZENECA PHARMACEUTICALS — Gaithersburg, MD

FDA drug recall D-0028-2026 was initiated by ASTRAZENECA PHARMACEUTICALS on Oct 8, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The recall status is ongoing. Affected quantity: 916 pre-filled syringes.

Recall Details

Product Type: Drugs
Report Date: Oct 22, 2025
Initiation Date: Oct 8, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 916 pre-filled syringes

Product Description

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:

Distribution Pattern

Nationwide in the U.S

Code Information

Lot YJ0152, Expiry: 01/31/2028.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0028-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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