# FDA recall D-0761-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2023-05-09.

## Product

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

## Reason for recall

Failed Dissolution Specifications; during stability testing

## Distribution

Nationwide in the U.S.A

## Key facts

- **Recall number:** D-0761-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-09
- **Report date:** 2023-05-31
- **Termination date:** 2024-02-27

- **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-0761-2023

## Citation

> AI Analytics. FDA recall D-0761-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0761-2023. Source: US FDA. Licensed CC0.

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