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Class IIIDrug recallOngoing

Everolimus tablets recall

Recalled by Endo USA, Inc. of Malvern, PA · FDA report 11/05/2025

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class III
Low risk
Status
Ongoing
Recall started
10/10/2025
Distribution
Nationwide

Reason for recall

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

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

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
Lot and code info
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Quantity
6,655 cartons
Recall number
D-0139-2026
Event ID
97866
Initiated by
Voluntary: Firm initiated

Where it was distributed

Nationwide within the United States

  • Nationwide

Recall timeline

  1. 10/10/2025Firm started the recall
  2. 10/29/2025FDA classified it as Class III
  3. 11/05/2025Published in the FDA enforcement report

All products in this recall

4 products under event 97866

More recalls from Endo USA

Frequently asked questions

Why was Everolimus tablets recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What does Class III mean?
Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?
Nationwide within the United States
Is this recall still active?
The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 11/05/2025 · Do not rely on openFDA to make decisions regarding medical care