July 2024 FDA Recall Clonazepam by Endo Pharmaceuticals, Inc.
D-0622-2024 - Labeling

This Class I drug recall was voluntarily initiated by Endo Pharmaceuticals, Inc. on July 10, 2024 for the product Clonazepam. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0622-2024

Reason for Recall
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.
Initiated
07-10-2024
Reported
08-07-2024
Quantity
8,139 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94945
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Endo Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-16-2025
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot 550147301, Exp. 08/31/2026

Affected Packages Involved in this Recall

49884-306-02 Clonazepam
49884-307-02 Clonazepam
49884-308-02 Clonazepam
49884-309-02 Clonazepam
49884-310-02 Clonazepam