Orkambi recalls

The FDA has published 2 recalls involving Orkambi since 2018. The latest was reported on 16 May 2018. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 May 2018

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why orkambi is recalled

Other Reasons2100%

Companies

Kroger Specialty Pharmacy2100%

By year

20182100%

All orkambi recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
16 May 2018Drug	CLASS II	Orkambi 200 mg/ #112 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states
16 May 2018Drug	CLASS II	Orkambi 100 mg/ #112 recalled by Kroger Specialty Pharmacy	Kroger Specialty Pharmacy	Other	5 states

Should you stop taking Orkambi?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.