American Regent, Inc. recalls Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regen…

Recall date

April 16, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0494-2026

FDA classification

Class III

Brand / firm

American Regent, Inc.

Sold / distributed

U.S. Nationwide

Why it was recalled

Labeling: Missing Label

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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