FDA Recall D-0180-2025

Endo USA, Inc. · Malvern, PA

Class I — life-threatening Ongoing 542 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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).

Lot / code: Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.

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.

Recall record

Recall number: D-0180-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2024-11-18
Classified by FDA Center: 2025-01-03
FDA published: 2025-01-15
Recalling firm: Endo USA, Inc.
Firm location: Malvern, PA

Drug identification

Brand name(s): CLONAZEPAM
Generic name(s): CLONAZEPAM
Manufacturer(s): Par Health USA, LLC
NDC(s): 49884-306, 49884-307, 49884-308, 49884-309, 49884-310
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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