Class IIIReported 2025-11-05
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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Recall NumberD-0139-2026ClassificationClass IIIStatusOngoingCategorydrugInitiated2025-10-10Reported2025-11-05DistributionNationwide within the United StatesCode InfoLot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.