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

Want Alerts Like This?

Get notified about recalls in categories you care about.

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

Related Recalls

HIGH

Lannett Company Recalls Niacin Tablets for Failed Dissolution

Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.

NIACIN
Failed Dissolution
Read more