Class IOngoing

Clonazepam Orally Disintegrating Tablets recall

FDA recall D-0181-2025 · initiated Nov 18, 2024

Most serious — a reasonable probability that use will cause serious harm or death.

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.

Details

Product: 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).
Recalling company: Endo Pharms
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Nov 18, 2024
FDA report date: Jan 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0181-2025 ↗

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