LEVOCARNITINE
Recalling Firm / Manufacturer: American Regent, Inc.
(New Albany, OH, United States)
FDA Recall Number: D-0494-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
LEVOCARNITINE
Generic Name
LEVOCARNITINE
Active Substance(s)
Levocarnitine
Administration Route
Intravenous
National Drug Code (NDC)
0517-1045
Total Quantity Recalled
74,040 Single Dose Vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Labeling: Missing Label
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
May 06, 2026
Firm Initiation Date
April 16, 2026
FDA Classification Date
Apr 28, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0494-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC