Astrazeneca Pharmaceuticals recalls
FDA enforcement reports naming ASTRAZENECA PHARMACEUTICALS as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 1
- Most recent report
- Oct 22, 2025
- Oct 22, 2025Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only…Drug · ASTRAZENECA PHARMACEUTICALSLack of Assurance of Sterility:Class II
- Mar 14, 2018Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra…Drug · AstraZeneca Pharmaceuticals LPFailed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).Class III
- Jul 19, 2017BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, MfdDrug · AstraZeneca Pharmaceuticals, LPPresence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.Class I
- Mar 30, 2016Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Met…Drug · AstraZeneca Pharmaceuticals LPDefective Delivery System: Some units have actuation counters set to a number other than 60.Class II
- Jun 24, 2015NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx…Drug · AstraZeneca Pharmaceuticals LPPresence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.Class II
- Aug 14, 2013MERREM IDrug · AstraZeneca Pharmaceuticals LPPresence of Precipitate; potential for incomplete constitution upon addition of diluent.Class II