Everolimus recalls

The FDA has published 5 recalls involving Everolimus since 2025. The latest was reported on 5 Nov 2025. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2025

Last 12 months5reported

Class I00% of total

Ongoing5latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 4 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 5 100%

Why everolimus is recalled

Potency & Assay5100%

Companies

Endo USA5100%

By year

20255100%

Ongoing everolimus recalls

5 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 10 mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 5 mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide

All everolimus recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 10 mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 5 mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS III	Everolimus tablets 5mg (each carton contains 4 blister recalled	Endo USA	Potency & Assay	Nationwide

Should you stop taking Everolimus?

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.