Endo USA, Inc. recalls Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Recalled October 22, 2025 · FDA recall D-0026-2026 · Endo USA
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. · FDA Class III
Units
1,041 cartons
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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
Manufacturer(s)
Endo USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →