# FDA recall D-0024-2023

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2022-10-18.

## Product

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only,  Distributed by:  Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83

## Reason for recall

Presence of Foreign Substance

## Distribution

Nationwide with the United States

## Key facts

- **Recall number:** D-0024-2023
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-10-18
- **Report date:** 2022-11-09
- **Termination date:** 2023-09-07

- **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-0024-2023

## Citation

> AI Analytics. FDA recall D-0024-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0024-2023. Source: US FDA. Licensed CC0.

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