# FDA recall D-0181-2025

> **Endo USA, Inc.** · Class I · drug recall initiated 2024-11-18.

## 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).

## Reason for recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0181-2025
- **Recalling firm:** Endo USA, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-18
- **Report date:** 2025-01-15

- **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-0181-2025

## Citation

> AI Analytics. FDA recall D-0181-2025. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0181-2025. Source: US FDA. Licensed CC0.

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