Drug & medication recalls High risk

Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing…

Recall date
November 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0181-2025
FDA classification
Class I
Brand / firm
Endo USA, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

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

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, 1 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#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).

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