# FDA recall D-0112-2025

> **Lannett Company Inc.** · Class II · drug recall initiated 2024-10-25.

## Product

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:  0527-4661-37

## Reason for recall

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0112-2025
- **Recalling firm:** Lannett Company Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-10-25
- **Report date:** 2024-12-11
- **Termination date:** 2025-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seymour, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2025

## Citation

> AI Analytics. FDA recall D-0112-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0112-2025. Source: US FDA. Licensed CC0.

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