FDA recall D-0141-2026

Endo USA, Inc. · Class III · drug

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2025-10-10
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2026