Class III

Drug Recall: 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

American Regent, Inc. · April 16, 2026

Reason for Recall

Labeling: Missing Label

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

74,040 Single Dose Vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0494-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

American Regent, Inc. Drug Recall: 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 | SafeCheck