AstraZeneca Lynparza 50mg Capsules Recall: Impurities Risk Serious Injury
AstraZeneca recalls Lynparza 50mg capsules due to impurities that could cause serious injury. Affected products have specific NDC codes and were sold between 02/2018 and 05/2018. Contact for return instructions.
Stop using this now
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Contact the company
What happened, in plain English
AstraZeneca is recalling Lynparza 50mg capsules because they contain impurities that could cause serious injury. This affects specific bottles sold between February and May 2018 with certain NDC codes. Read more at govinfonow.com/recall/40800-astrazeneca-lynparza-50mg-capsules-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/40800-astrazeneca-lynparza-50mg-capsules-recall-impurities-risk-serious-injury · Updated October 7, 2026 · FDA enforcement record: FDA #D-0585-2018
Cite this page
“AstraZeneca Lynparza 50mg Capsules Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40800-astrazeneca-lynparza-50mg-capsules-recall-impurities-risk-serious-injury. Based on FDA recall #D-0585-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0585-2018%22&limit=1).
Why it’s dangerous
The capsules contain elevated levels of a specific impurity (polymorph) that could cause serious injury if taken. This impurity is a quality issue that affects the safety of the medication.
Who’s affected
Patients prescribed Lynparza for cancer treatment who have the specific 50mg capsules with NDC 0310-0657-58. Those who have taken the capsules without a doctor's prescription are not affected.
How to tell if you have this one
Check for the NDC code 0310-0657-58 on the bottle. The capsules were manufactured by Patheon Pharmaceuticals in Cincinnati, OH and sold between February and May 2018.
- Brand
AstraZeneca- Category
Drug
What to do — step by step
Stop Using Capsules
Immediately stop using the recalled Lynparza capsules if you have them.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0585-2018 (February 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0585-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.