Prescription medicine
Levocarnitine Brand names: Carnitor
Levocarnitine (Carnitor) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.671 per levocarnitine 330 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the levocarnitine FDA label on DailyMed (effective November 4, 2024, Leadiant Biosciences, Inc.); the NDA 18948 record on Drugs@FDA; every levocarnitine label on DailyMed.
Highlights of the record
FDA label of November 4, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCARNITOR ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency.
Forms and strengths
- 330 mg
- 1 g/10ml
- 1 g/5ml
- 200 mg/ml
Solution; injection (solution); tablet; injection.
On the market
- Earliest approval on file
- December 27, 1985 Carnitor, Leadiant Biosci Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first March 29, 2001; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.671 per tablet Levocarnitine 330 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 0 Class I among all firms' recalls; latest April 16, 2026; 7 more by firms not listed as its makers
- FAERS reports
- 3,587 through July 30, 2026
What is levocarnitine used for?
From the label: indications and usageCARNITOR ® (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. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ). […]
FDA pharmacologic class: Carnitine Analog.
Source: FDA drug label (Carnitor SF), Leadiant Biosciences, Inc., effective November 4, 2024 (SPL set dd904490-83f3-4cd3-bb6f-68e28509b4b6), via openFDA; the full label on DailyMed
Is there a generic for levocarnitine (Carnitor)?
The FDA approved the first generic levocarnitine on March 29, 2001. 12 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists levocarnitine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1985 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levocarnitine (Carnitor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.671 per Levocarnitine 330 mg tablet, down 10% from $0.744 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Levocarnitine 1 g/10 mL solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levocarnitine 1 g/10 mL solution | Generic | $0.145 per mL | n/a | +0.8% |
| Levocarnitine 330 mg tablet | Generic | $0.671 per tablet | $20.12 | -10% |
| Levocarnitine sf 1 g/10 mL solution | Generic | $0.252 per mL | n/a | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has levocarnitine been recalled?
The FDA's Enforcement Report lists 9 recalls naming levocarnitine since 2014: 0 Class I (the most serious), 8 Class II, 1 Class III; 3 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of levocarnitine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 16, 2026 | Class III | American Regent, Inc. | Labeling: Missing Label |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| March 7, 2022 | Class II | TMC Acquisition LLC dba Tailor Made Compounding not a listed maker | Lack of Assurance of Sterility |
| August 13, 2021 | Class II | First Royal Care Co. LLC, dba Red Mountain Compounding … not a listed maker | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| September 10, 2018 | Class II | Pharm D Solutions, LLC | Lack of Assurance of Sterility |
| May 17, 2016 | Class II | Well Care Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. |
| May 12, 2014 | Class II | John W Hollis Inc not a listed maker | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levocarnitine label say about other medicines?
The levocarnitine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drug Interactions Reports of INR increase with the use of warfarin have been observed. |
Source: FDA drug label (Carnitor SF), Leadiant Biosciences, Inc., effective November 4, 2024 (SPL set dd904490-83f3-4cd3-bb6f-68e28509b4b6), via openFDA; the full label on DailyMed
What do FAERS reports show for levocarnitine?
The FDA Adverse Event Reporting System holds 3,587 reports that list levocarnitine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 392 are coded as a death and 1,693 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Levocarnitine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other