HIGH

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

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

Quick Facts at a Glance

Recall Date
September 5, 2025
Hazard Level
HIGH
Brands
EVEROLIMUS, ENDO USA, Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Endo USA, Inc. or your healthcare provider for guidance. Notification method: Letter

Full Description

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. Generic: EVEROLIMUS; Brand: EVEROLIMUS. Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.. Classification: Class III. Quantity: 1,041 cartons. Distribution: Nationwide within the United States

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot #: 550172301
Exp. Date January 2026
UPC Codes
49884-119
49884-125
49884-127
+9 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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