# FDA recall D-0457-2025

> **Apotex Corp.** · Class II · drug recall initiated 2025-05-28.

## Product

Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4

## Reason for recall

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0457-2025
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-28
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0457-2025

## Citation

> AI Analytics. FDA recall D-0457-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0457-2025. Source: US FDA. Licensed CC0.

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