# FDA recall D-0437-2017

> **Roxane Laboratories, Inc.** · Class II · drug recall initiated 2016-12-22.

## Product

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio  43216, NDC 0054-4297-31.

## Reason for recall

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0437-2017
- **Recalling firm:** Roxane Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-22
- **Report date:** 2017-02-01
- **Termination date:** 2017-12-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0437-2017

## Citation

> AI Analytics. FDA recall D-0437-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0437-2017. Source: US FDA. Licensed CC0.

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