# FDA recall D-0858-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2022-04-29.

## Product

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, 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, NDC 47335-738-86

## Reason for recall

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0858-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-29
- **Report date:** 2022-05-18
- **Termination date:** 2023-09-25

- **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-0858-2022

## Citation

> AI Analytics. FDA recall D-0858-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0858-2022. Source: US FDA. Licensed CC0.

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