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Class I · Most seriousRecall completed

Clonazepam

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot 550147301, Exp. 08/31/2026
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPar Health USA, LLC
Brand nameCLONAZEPAM
Generic nameCLONAZEPAM
Active ingredient(s)CLONAZEPAM
Distributed by / forPar Pharmaceutical, Chestnut Ridge, NY 10977
NDC49884-306-02
Show the full FDA record
Full product labelClonazepam 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.
Recalling firmEndo Pharmaceuticals, Inc.
DistributionNationwide in the USA and Puerto Rico
Quantity8,139 cartons
Recall initiated2024-07-10
Report date2024-08-07
Recall completed2025-09-16
Recall numberD-0622-2024
ClassificationClass I
FDA statusTerminated
Origin on fileMalvern PA United States

Related

Clonazepam recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.