Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each),...
FDA Recall #D-0141-2026 — Class III — October 10, 2025
Product Description
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
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
935 cartons
Distribution
Nationwide within the United States
Code Information
Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated