FDAHealthApril 16, 2026
American Regent, Inc. — 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 16, 2026
U.S. Nationwide
What's affected?
- 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
- Brand
- LEVOCARNITINE
- Lot code
- 24159N0C0
Additional details
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 74,040 Single Dose Vials.
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