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Recall Enforment Report D-0140-2026

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Endo USA, Inc., originally initiated on 10-10-2025 for the product Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 The product was recalled due to failed impurities/degradation specifications: out of specification for impurity ip-c.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0140-202610-10-202511-05-2025Class III1,866 cartonsEverolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Ongoing
D-0142-202610-10-202511-05-2025Class III2,035 cartonsEverolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Ongoing
D-0139-202610-10-202511-05-2025Class III6,655 cartonsEverolimus 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# 49884-125-91Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Ongoing
D-0141-202610-10-202511-05-2025Class III935 cartonsEverolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
49884-119Everolimus EverolimusTabletOralEndo Usa, Inc.Human Prescription Drug
49884-125Everolimus EverolimusTabletOralEndo Usa, Inc.Human Prescription Drug
49884-127Everolimus EverolimusTabletOralEndo Usa, Inc.Human Prescription Drug
49884-128Everolimus EverolimusTabletOralEndo Usa, Inc.Human Prescription Drug