# FDA recall D-1030-2016

> **Nostrum Laboratories, Inc.** · Class II · drug recall initiated 2016-05-23.

## Product

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1030-2016
- **Recalling firm:** Nostrum Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-23
- **Report date:** 2016-06-22
- **Termination date:** 2017-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bryan, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2016

## Citation

> AI Analytics. FDA recall D-1030-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1030-2016. Source: US FDA. Licensed CC0.

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