Information
Endo USA Recalls Everolimus tablets 7.5mg
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0140-2026Drug / Pharmaceutical
Endo USA Recalls Everolimus tablets 7.5mg
Endo USA, Inc. · Class III — Regulatory
Product Description
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Endo USA, Inc. initiated a Class III recall of a pharmaceutical product on October 10, 2025 affecting 1,866 cartons. Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.