FDA Drug · D-0178-2025

Clonazepam 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).

Class I · Ongoing

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Affected lots / codes — check yours against thisLot # 550176501, 550176601, Exp 02/28/2027.

Recalling firm: Endo USA, Inc., Malvern, PA
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 9,816 cartons
Distribution: Nationwide in the USA
Recall initiated: November 18, 2024
Classified: January 3, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0178-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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