Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Everolimus tablets 5mg Recalled by Endo USA, Inc. Due to Failed Impurities/Degradation Specifications: Out of specification for impurity...

Date: September 5, 2025
Company: Endo USA, Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Endo USA, Inc. directly.

Affected Products

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

Quantity: 1,041 cartons

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Endo USA, Inc.

Endo USA, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report