Recall: D-0494-2026

Class III - Minor Violations

Class IIIClassification

2026-04-16Initiated

OngoingStatus

American Regent, Inc.Firm

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

Labeling: Missing Label

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.