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Recall Observatory FDA recall evidence

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

D-0141-2026

October 10, 2025

Class III

Product summary

Firm
Endo USA, Inc.
Event
Event 97866
Status
Ongoing
Classification
Class III
Quantity
935 cartons
Official record key
drug-enforcement:D-0141-2026

Official wording

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

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