# FDA recall D-0599-2025

> **Lannett Company Inc.** · Class II · drug recall initiated 2025-08-11.

## Product

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

## Reason for recall

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-0599-2025
- **Recalling firm:** Lannett Company Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2025-08-11
- **Report date:** 2025-09-03

- **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-0599-2025

## Citation

> AI Analytics. FDA recall D-0599-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0599-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
