Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0142-2026

October 10, 2025

Class III

Product summary

Firm
Endo USA, Inc.
Event
Event 97866
Status
Ongoing
Classification
Class III
Quantity
2,035 cartons
Official record key
drug-enforcement:D-0142-2026

Official wording

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

Code information: Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification