The Recall Desk
HighFDA (Drugs)·D-0028-2026·Announced 2025-10-22

FASENRA (Benralizumab) Injectable Drug Recall Due to Sterility

AstraZeneca is recalling FASENRA (benralizumab) pre-filled syringes due to lack of assurance of sterility. Patients who received injections from the recalled lot should contact their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance on an injectable medication. No illnesses or injuries are reported. The recall addresses a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

AstraZeneca Pharmaceuticals is recalling 916 pre-filled syringes of FASENRA (benralizumab) Injection, 30 mg/mL due to lack of assurance of sterility. The recalled product is Lot YJ0152, which has an expiration date of January 31, 2028, and was distributed nationwide in the United States. The recall is due to inability to assure the sterility of this specific lot.

Patients who received injections from Lot YJ0152 should contact their healthcare provider. Healthcare providers who received FASENRA from this lot should verify their patient records to identify anyone who may have been treated with the recalled product and follow guidance from AstraZeneca Pharmaceuticals and the FDA.

The recalled product

Product
FASENRA (BENRALIZUMAB)
Brand
FASENRA
Manufacturer
ASTRAZENECA PHARMACEUTICALS
Category
Drug — Injectable / Biologic
Hazard
  • sterility-assurance
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot YJ0152
  • Expiry: 01/31/2028.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category