United StatesEverolimus tablets 5 mg, 28‑count cartons (4 blister strips of 7 tablets), NDC 49884‑125‑91, lot 550172301, exp. January 2026, manufactured by Par Pharmaceutical and distributed by Endo USA, are being recalled nationwide in the United States. The recall was initiated because the product tested out of specification for impurity IP‑C.
What's being recalled
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Recalling firm: Endo USA, Inc., Malvern, PA, United States.
How to identify it
Lot #: 550172301, Exp. Date January 2026
The hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)