FDAFDA · Food and drugs·Recall number D-0180-2025
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).
Published January 15, 2025 · Recall initiated: November 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- CLONAZEPAM
- Manufacturer
- Endo USA, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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