Information
American Regent Recalls Levocarnitine Injection
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0494-2026Drug / Pharmaceutical
American Regent Recalls Levocarnitine Injection
American Regent, Inc. · Class III — Regulatory
Product Description
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
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
American Regent, Inc. initiated a Class III recall of a pharmaceutical product on April 16, 2026 affecting 74,040 Single Dose Vials. Labeling: Missing Label. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed in U.S. Nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.