Endo Pharmaceuticals, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tabl…

Recall date

July 10, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0622-2024

FDA classification

Class I

Brand / firm

Endo Pharmaceuticals, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.