# FDA recall D-0502-2017

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2017-01-05.

## Product

Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.

## Reason for recall

Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0502-2017
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-05
- **Report date:** 2017-03-08
- **Termination date:** 2018-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cranbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0502-2017

## Citation

> AI Analytics. FDA recall D-0502-2017. Retrieved 2026-05-30 from https://api.ai-analytics.org/recall/D-0502-2017. Source: US FDA. Licensed CC0.

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