Olanzapine recalls

The FDA has published 14 recalls involving Olanzapine since 2013. The latest was reported on 25 Dec 2024. Most were for potency & assay. Sun Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls14since 2013
Last 12 months0reported
Class I00% of total
Ongoing1latest 25 Dec 2024

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 5 36%Class III 9 64%

By year

Ongoing olanzapine recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIOlanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapineMacleods PharmaceuticalsPotency & AssayNationwide

All olanzapine recalls, newest first

14 total

Should you stop taking Olanzapine?

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.