Everolimus Tablets 5mg (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
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Endo USA, Inc.
Lot Codes / Batch Numbers
Lot #: 550184901, 550185001, Exp. Date MAR-26, 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Products Sold
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Endo USA, Inc. is recalling Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx o 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
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026