EVEROLIMUS
Recalling Firm / Manufacturer: Endo USA, Inc.
(Malvern, PA, United States)
FDA Recall Number: D-0139-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
EVEROLIMUS
Generic Name
EVEROLIMUS
Active Substance(s)
Everolimus
Administration Route
Oral
National Drug Code (NDC)
49884-119
Total Quantity Recalled
6,655 cartons
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
November 05, 2025
Firm Initiation Date
October 10, 2025
FDA Classification Date
Oct 29, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Distribution Information
Geographic scope of affected shipments
Nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0139-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC