⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Endo USA, Inc.: Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical

DrugsSource: FDA (drug) · Date: 2025-10-22

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Endo USA, Inc.
Product
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
Reason / hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-09-05
Code info
Lot #: 550172301, Exp. Date January 2026
Product quantity
1,041 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Malvern
State
PA
Country
United States
Event id
97557
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