Levocarnitine Injection USP Missing Label Recall
American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a labeling defect (missing label). Per the rubric, Class III recalls are by definition unlikely to cause adverse health consequences, and labeling-only problems without evidence of harm are typically scored as 1 (Low).
Plain-English summary
American Regent, Inc. is recalling Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), in 5 mL single-dose vials due to missing labeling. The recall affects 74,040 vials from two lots: Lot 24159N0C0 (expiration June 30, 2026) and Lot 25193N0C0 (expiration July 31, 2027), NDC 0517-1045-01.
The product was distributed nationwide to healthcare facilities and providers. Levocarnitine Injection, USP is a prescription medication administered intravenously and is used to treat carnitine deficiency.
Patients and healthcare providers should not use affected vials and should contact their suppliers for return or replacement instructions. Healthcare facilities and distributors who received this product should verify their inventory against the affected lot numbers.
The recalled product
- Product
- LEVOCARNITINE (LEVOCARNITINE)
- Brand
- LEVOCARNITINE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injectable / Intravenous
- Hazard
- missing-label
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot 24159N0C0
- Exp. June 30
- 2026 Lot 25193N0C0
- Exp. July 31
- 2027
Distribution
Distributed nationwide across the United States.