Fasenra prefilled syringes recalled from one lot over sterility assurance
AstraZeneca is recalling 916 pre-filled syringes of Fasenra (benralizumab) Injection 30 mg/mL from one lot for lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
Fasenra (benralizumab) Injection, 30 mg/mL in a single-dose pre-filled syringe, manufactured by AstraZeneca AB in Sweden and distributed by AstraZeneca Pharmaceuticals of Wilmington, Delaware, is being recalled for lack of assurance of sterility.
The recall covers 916 pre-filled syringes from lot YJ0152, expiring 31 January 2028, carrying NDC 0310-1730-30. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Patients holding a syringe from the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- FASENRA (BENRALIZUMAB)
- Brand
- FASENRA
- Manufacturer
- ASTRAZENECA PHARMACEUTICALS
- Category
- Drug — Injectable
- Affected units
- 916
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.
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