Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL)
Recalled by American Regent, Inc.
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
American Regent, Inc. has recalled Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 6, 2026 and was initiated on April 16, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), with approximately 74,040 Single Dose Vials affected. The company behind the recall is American Regent, Inc., based in New Albany, OH. The FDA describes the product as: “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”
Why was Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL) recalled?
According to the FDA, the stated reason for the recall is: “Labeling: Missing Label.”
What should you do?
If you think you may have bought Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), compare it against the product description and identifying codes (Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact American Regent, Inc. or your local health authority.
About this recall
This recall was distributed in OH. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- May 6, 2026
- Recall started
- April 16, 2026
- Distributed in
- OH
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL) recalled?+
According to the FDA: Labeling: Missing Label
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL)?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0494-2026. Information last synced from the FDA on July 6, 2026.