Endo USA, Inc. recalls Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Recalled November 5, 2025 · FDA recall D-0141-2026 · Endo USA
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. · FDA Class III
Units
935 cartons
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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
Manufacturer(s)
Endo USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →