Wilmington, DE, United States
AstraZeneca Pharmaceuticals LP recalls
2 recalls recorded since 2018, most recently on 8 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 8 October 2025
- Reason
- Lack of Assurance of Sterility:
- Distribution
- Nationwide in the U.S
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0028-2026
- 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
Terminated Class III Drugs
- Recall started
- 23 February 2018
- Terminated
- 26 February 2019
- Reason
- Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0585-2018
- Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.