American Regent, Inc. recalls Levocarnitine Injection
- Recalling company
- American Regent, Inc.
- 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
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Apr 16, 2026
- Reported
- May 6, 2026
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 74,040 Single Dose Vials
- Lot / codes
- Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
- Company location
- New Albany, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0494-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0494-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.