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FDAFDA · Food and drugs·Recall number D-0142-2026

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

Published November 5, 2025 · Recall initiated: October 10, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Endo USA, Inc.
Distributor
Nationwide within the United States
Lot
Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
Risk classification
Class III
Area (FDA)
drug
Country
United States

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