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 Regent
Recalled May 6, 2026 · FDA recall D-0494-2026 · American Regent
Hazard
Labeling: Missing Label · FDA Class III
Units
74,040 Single Dose Vials
Sold at
U.S. Nationwide
Description
Labeling: Missing Label
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
Manufacturer(s)
American Regent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →