Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), R...
FDA Recall #D-0139-2026 — Class III — October 10, 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
6,655 cartons
Distribution
Nationwide within the United States
Code Information
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated