Endo USA, Inc.: Drug Recall
Recall #D-0180-2025 · 11/18/2024
Class I: Dangerous
Recall Details
- Recall Number
- D-0180-2025
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Endo USA, Inc.
- Status
- Ongoing
- Date Initiated
- 11/18/2024
- Location
- Malvern, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72,973 cartons
Reason for Recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Product Description
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).
Distribution Pattern
Nationwide in the USA
Other Recalls by Endo USA, Inc.
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 09/05/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.