Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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

Recalling firm: Endo USA, Inc.
NDC code: 49884-125-91
Origin: PA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0139-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Everolimus recalls

See all

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

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

Endo USA, Inc. NDC 49884-119-91 D-0142-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

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

Endo USA, Inc. NDC 49884-128-91 D-0141-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

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

Endo USA, Inc. NDC 49884-127-91 D-0140-2026

Class III · Low risk Ongoing Sep 5, 2025