WhichRecall
Class IIIReported 2025-10-22

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91

Recalled by Endo USA, Inc.

Reason for Recall

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

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Recall Number
D-0026-2026
Classification
Class III
Status
Ongoing
Category
drug
Initiated
2025-09-05
Reported
2025-10-22
Distribution
Nationwide within the United States
Code Info
Lot #: 550172301, Exp. Date January 2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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