Recall D-0026-2026

US Class III Ongoing · initiated 2025-09-05

Recalling firm

Endo USA, Inc., PA

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

Reason for recall

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

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