# FDA recall D-1155-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-06-03.

## Product

Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512,  NDC 57664-783-68, packaged in bottles.

## Reason for recall

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

## Distribution

nationwide within the United States

## Key facts

- **Recall number:** D-1155-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-03
- **Report date:** 2022-06-29
- **Termination date:** 2023-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1155-2022

## Citation

> AI Analytics. FDA recall D-1155-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1155-2022. Source: US FDA. Licensed CC0.

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