# FDA recall D-0622-2024

> **Endo Pharmaceuticals, Inc.** · Class I · drug recall initiated 2024-07-10.

## 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.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0622-2024
- **Recalling firm:** Endo Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-07-10
- **Report date:** 2024-08-07
- **Termination date:** 2025-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0622-2024

## Citation

> AI Analytics. FDA recall D-0622-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0622-2024. Source: US FDA. Licensed CC0.

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