HIGH

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

Labeling: Missing Label

Quick Facts at a Glance

Recall Date
April 16, 2026
Hazard Level
HIGH
Brands
LEVOCARNITINE, American Regent, Inc.
Geographic Scope
1 states

Hazard Information

Labeling: Missing Label

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact American Regent, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full 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. Generic: LEVOCARNITINE; Brand: LEVOCARNITINE. Reason: Labeling: Missing Label. Classification: Class III. Quantity: 74,040 Single Dose Vials. Distribution: U.S. Nationwide

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot 24159N0C0
Exp. June 30
2026 Lot 25193N0C0
Exp. July 31
2027
UPC Codes
0517-1045
0517-1075
0517-1045-01
+2 more
Affected States
ALL
Report Date
May 6, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE