Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Summary
The FDA issued a Class III for Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 by Endo USA, Inc.. Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C..
Details
Source
Drug Recall
External ID
D-0139-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Quantity Affected: 6,655 cartons
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-10
Company
Malvern, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Endo USA, Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Endo USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Endo USA, Inc. have FDA actions?
Endo USA, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0139-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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