FDA recall D-0494-2026

American Regent, Inc. · Class III · drug

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

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

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