# FDA recall D-0818-2018

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2018-04-26.

## Product

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

## Reason for recall

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

## Distribution

US Nationwide in the USA

## Key facts

- **Recall number:** D-0818-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-26
- **Report date:** 2018-05-23
- **Termination date:** 2019-02-28

- **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-0818-2018

## Citation

> AI Analytics. FDA recall D-0818-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0818-2018. Source: US FDA. Licensed CC0.

---

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