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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fasenra (benralizumab) Injection Recalled for Lack of Sterility

Agency Publication Date: October 16, 2025
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Summary

AstraZeneca Pharmaceuticals has voluntarily recalled 916 units of Fasenra (benralizumab) Injection, 30 mg/mL, because there is a lack of assurance regarding the product's sterility. Fasenra is a prescription medication provided in a single-dose pre-filled syringe for the treatment of severe asthma. This recall affects a specific production lot (YJ0152) distributed nationwide across the United States. If you are a patient using this medication, you should contact your healthcare provider or pharmacist immediately to discuss your treatment options and ensure you have a safe supply.

Risk

A lack of sterility assurance means the medication may not be free from microorganisms, which can lead to serious or life-threatening infections if injected into the body. No injuries or adverse events have been reported to date, but the risk remains significant for a sterile injectable product.

What You Should Do

  1. Check your medication packaging for Fasenra (benralizumab) Injection, 30 mg/mL, in a single-dose pre-filled syringe.
  2. Identify if your product belongs to Lot YJ0152 with an expiration date of 01/31/2028 and NDC 0310-1730-30.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fasenra (benralizumab) Injection (30 mg/mL)
Variants: 30 mg/mL, Single-dose pre-filled syringe
Lot Numbers:
YJ0152 (Exp: 01/31/2028)
NDC:
0310-1730-30

Recall #: D-0028-2026; Quantity: 916 pre-filled syringes; Manufactured by AstraZeneca AB, Sweden.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97760
Status: Active
Manufacturer: ASTRAZENECA PHARMACEUTICALS
Sold By: Specialty pharmacies; Hospitals; Healthcare providers
Manufactured In: Sweden, United States
Units Affected: 916 pre-filled syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.