Lynparza — Class III drug recall D-0585-2018
Terminated recall by AstraZeneca Pharmaceuticals LP, reported 2018-03-14, distributed nationwide. Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
| Recall number | D-0585-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AstraZeneca Pharmaceuticals LP, Wilmington, DE, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 18,056 bottles |
| Reason classes | specification failure |
| NDC | 00310-0657-58 |
Product
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 0310-0657-58
Reason for recall
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0585-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.