Class III

Drug Recall: Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

Endo USA, Inc. · October 10, 2025

Reason for Recall

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

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

2,035 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0142-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Endo USA, Inc. Drug Recall: Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 | SafeCheck