← FDA ENFORCEMENT
D-0179-2025Class I

Endo USA, Inc.

Recalling firm
Endo USA, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-01-15
Distribution
Nationwide in the USA
Firm state
PA
Product quantity
8,029 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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, 0.125 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).

Code / lot info

Lot #: 550174101, Exp. 01/31/2027.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.