Reported Aug 7, 2024 · Terminated

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6…

Endo Pharmaceuticals, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Endo Pharmaceuticals, Inc. · 1400 Atwater Dr · Malvern, PA · 19355-8701

Is this the product you have?

  • Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only
  • Distributed byPar Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02
Lot codes and dates
    • Lot 550147301
    • Exp. 08/31/2026
Amount recalled
8,139 cartons

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 16, 2025 · Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.