# FDA recall D-0927-2018

> **LUPIN SOMERSET** · Class II · drug recall initiated 2018-06-28.

## Product

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

## Reason for recall

Subpotent Drug and Failed Content Uniformity.

## Distribution

Nationwide within the US

## Key facts

- **Recall number:** D-0927-2018
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-28
- **Report date:** 2018-07-18
- **Termination date:** 2023-03-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0927-2018

## Citation

> AI Analytics. FDA recall D-0927-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0927-2018. Source: US FDA. Licensed CC0.

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