Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), R...
FDA Recall #D-0026-2026 — Class III — September 5, 2025
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Recalling Firm
Endo USA, Inc. — Malvern, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,041 cartons
Distribution
Nationwide within the United States
Code Information
Lot #: 550172301, Exp. Date January 2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated