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Recall Observatory FDA recall evidence

Drug product

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

D-0140-2026

October 10, 2025

Class III

Product summary

Firm
Endo USA, Inc.
Event
Event 97866
Status
Ongoing
Classification
Class III
Quantity
1,866 cartons
Official record key
drug-enforcement:D-0140-2026

Official wording

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

Code information: Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, 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