Home / Recalls / ASTRAZENECA PHARMACEUTICALS / D-0028-2026

D-0028-2026 Class II Ongoing

Recalled by ASTRAZENECA PHARMACEUTICALS — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
October 22, 2025
Initiation Date
October 8, 2025
Termination Date
N/A
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.

Other recalls by ASTRAZENECA PHARMACEUTICALS

  • D-0585-2018 Class III — Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for (February 23, 2018)
  • D-0958-2017 Class I — BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx on (May 25, 2017)
  • D-0781-2016 Class II — Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, (February 5, 2016)
  • D-1141-2015 Class II — NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bott (June 10, 2015)
  • D-840-2013 Class II — MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx (June 21, 2013)