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  3. Recall Enforcement Event ID: 95778

Recall Enforment Report D-0180-2025

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Endo USA, Inc., originally initiated on 11-18-2024 for the product Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters). The product was recalled due to labeling: label error on declared strength; some cartons were incorrectly labeled. the blister strips inside the product carton reflect the correct strength.. 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-0180-202511-18-202401-15-2025Class I72,973 cartonsClonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Ongoing
D-0178-202511-18-202401-15-2025Class I9,816 cartonsClonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Ongoing
D-0179-202511-18-202401-15-2025Class I8,029 cartonsClonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Ongoing
D-0181-202511-18-202401-15-2025Class I22,513 cartonsClonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
49884-306Clonazepam ClonazepamTablet, Orally DisintegratingOralPar Health Usa, LlcHuman Prescription Drug
49884-307Clonazepam ClonazepamTablet, Orally DisintegratingOralPar Health Usa, LlcHuman Prescription Drug
49884-308Clonazepam ClonazepamTablet, Orally DisintegratingOralPar Health Usa, LlcHuman Prescription Drug
49884-309Clonazepam ClonazepamTablet, Orally DisintegratingOralPar Health Usa, LlcHuman Prescription Drug
49884-310Clonazepam ClonazepamTablet, Orally DisintegratingOralPar Health Usa, LlcHuman Prescription Drug