PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: October 22, 2025 Initiated: September 5, 2025 #D-0026-2026

Product 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

Reason for Recall

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

Details

Recalling Firm
Endo USA, Inc.
Units Affected
1,041 cartons
Distribution
Nationwide within the United States
Location
Malvern, PA

Frequently Asked Questions

What product 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. Recalled by Endo USA, Inc.. Units affected: 1,041 cartons.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 22, 2025. Severity: Low. Recall number: D-0026-2026.