US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 23, 2018 (9 years ago)

Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).

What was recalled

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

Recalling firm
AstraZeneca Pharmaceuticals LP
NDC code
0310-0657-58
Origin
DE, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0585-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.