# FDA recall D-0085-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-12-01.

## Product

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

## Reason for recall

Presence of foreign substance

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0085-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-01
- **Report date:** 2022-12-28
- **Termination date:** 2023-09-13

- **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-0085-2023

## Citation

> AI Analytics. FDA recall D-0085-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0085-2023. Source: US FDA. Licensed CC0.

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