FDA Drug recall D-0585-2018
Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by:…
- FDA Drug
- Class III
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class III recall of Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by:… by Astrazeneca Pharmaceuticals, citing failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0585-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Astrazeneca Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Identifiers
| code_info | HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0585-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.