# FDA recall D-0924-2018

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2018-07-03.

## Product

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02

## Reason for recall

Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.

## Distribution

AZ

## Key facts

- **Recall number:** D-0924-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-03
- **Report date:** 2018-07-25
- **Termination date:** 2019-11-05

- **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-0924-2018

## Citation

> AI Analytics. FDA recall D-0924-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0924-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*