Quick answers
- What is Levocarnitine used for?
- The FDA-approved label (Carnitor, Leadiant Biosciences, Inc., October 30, 2024) says: “CARNITOR ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levocarnitine have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Levocarnitine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levocarnitine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 16, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Levocarnitine?
- 10 companies list prescription products of Levocarnitine in the FDA NDC Directory, including Leadiant Biosciences, Inc., ANI Pharmaceuticals, Inc. and Rising Pharma Holdings, Inc..
What Levocarnitine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CARNITOR ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. …
— FDA label: Carnitor, Leadiant Biosciences, Inc., effective October 30, 2024. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Injection, solution · Tablet · Injection |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Carnitor, Carnitor Sf |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| levocarnitine 1 g/10 mL solution | Generic | $0.1439–$0.2537 per mL 4 packages, lowest to highest |
| levocarnitine 1 g/10 mL solution | Brand: Carnitor SF | $0.5426 per mL |
| levocarnitine 330 mg tablet | Generic | $0.6646 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Leadiant Biosciences, Inc.4 products
- ANI Pharmaceuticals, Inc.3 products
- Rising Pharma Holdings, Inc.2 products
- American Regent, Inc.2 products
- Baxter Healthcare Corporation1 product
- Saptalis Pharmaceuticals, LLC.1 product
- Gland Pharma Limited1 product
- TruPharma, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Devatis, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018948 CARNITOR | Leadiant Biosci Inc | December 27, 1985 | 22, latest April 17, 2018 2018: Labeling · 2015: Labeling · 2013: Manufacturing (CMC) |
| NDA019257 CARNITOR, CARNITOR SF | Leadiant Biosci Inc | April 10, 1986 | 12, latest April 17, 2018 2018: Labeling · 2015: Labeling · 2007: Manufacturing (CMC) |
| NDA020182 CARNITOR | Leadiant Biosci Inc | December 16, 1992 | 10, latest April 17, 2018 2018: Labeling · 2015: Labeling · 2002: Labeling |
Generic approvals (10)
- ANDA075567Hikma · March 29, 2001
- ANDA075861Am Regent · June 22, 2001
- ANDA076851Rising · August 10, 2004
- ANDA076858Rising · September 20, 2004
- ANDA211676Novitium Pharma · August 14, 2019
- ANDA212533Sciegen Pharms · November 10, 2021
- ANDA216384Novitium Pharma · December 9, 2022
- ANDA217430Deva Holding As · June 30, 2025
- ANDA217896Baxter Hlthcare Corp · July 2, 2026
- ANDA220181Gland · September 30, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 16, 2026 · Class III · Ongoing · D-0494-2026
Labeling: Missing Label
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 — American Regent, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Carnitor, Leadiant Biosciences, Inc., effective October 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →