# FDA recall D-0137-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2023-11-22.

## Product

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0137-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-11-22
- **Report date:** 2023-12-13
- **Termination date:** 2024-06-27

- **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-0137-2024

## Citation

> AI Analytics. FDA recall D-0137-2024. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/D-0137-2024. Source: US FDA. Licensed CC0.

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