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

Recall Number: D-0139-2026

Firm: Endo USA, Inc.

Classification: Class III

Status: Ongoing

Report Date: 20251105

Initiation Date: 20251010

Termination Date:

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

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