D-0141-2026 Class III Ongoing

Recalled by Endo USA, Inc. — Malvern, PA

Recall Details

Product Type
Drugs
Report Date
November 5, 2025
Initiation Date
October 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
935 cartons

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26