# FDA recall D-1183-2018

> **Akorn, Inc.** · Class II · drug recall initiated 2018-08-24.

## Product

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1183-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-24
- **Report date:** 2018-09-12
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1183-2018

## Citation

> AI Analytics. FDA recall D-1183-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1183-2018. Source: US FDA. Licensed CC0.

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