# FDA recall D-0494-2026

> **American Regent, Inc.** · Class III · drug recall initiated 2026-04-16.

## Product

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967.  NDC: 0517-1045-01

## Reason for recall

Labeling: Missing Label

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0494-2026
- **Recalling firm:** American Regent, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-16
- **Report date:** 2026-05-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0494-2026

## Citation

> AI Analytics. FDA recall D-0494-2026. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0494-2026. Source: US FDA. Licensed CC0.

---

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