Everolimus Tablets 10mg (Endo USA) – Impurity Specification (2025)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Endo USA, Inc.
Lot Codes / Batch Numbers
Lot #: 550162801, Exp. Date NOV-25, 550169801, Exp. Date JAN-26
Products Sold
Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
Endo USA, Inc. is recalling Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx due to Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.