Lower risk Drug recall · FDA · Published April 16, 2026

American Regent Levocarnitine Injection Recall: Missing Label Hazard

American Regent recalls Levocarnitine Injection vials with missing labels. This labeling issue may lead to incorrect use. Contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0494-2026Drug American Regent ›

Lower-risk recall

Labeling: Missing Label

Take action

Contact the company

Recalling firmAmerican Regent, Inc.6610 New Albany Rd E · New Albany, OH 43054-8730

✎ GovInfoNow plain-language explainer

American Regent is recalling Levocarnitine Injection vials due to missing labels. This could cause incorrect use of the medication, especially since it's a prescription drug for intravenous use. Read more at govinfonow.com/recall/31347-american-regent-levocarnitine-injection-recall-missing-label-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/31347-american-regent-levocarnitine-injection-recall-missing-label-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0494-2026

Cite this page

“American Regent Levocarnitine Injection Recall: Missing Label Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31347-american-regent-levocarnitine-injection-recall-missing-label-hazard. Based on FDA recall #D-0494-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2026%22&limit=1).

The FDA announced on April 16, 2026, that American Regent, Inc. is recalling Levocarnitine Injection, USP due to missing labeling. The recall affects 74,040 single-dose vials distributed nationwide.

How to tell if you have it

Brand: American Regent
Product: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial
NDC: 0517-1045-01
Lot 24159N0C0, Exp. June 30, 2026
Lot 25193N0C0, Exp. July 31, 2027

The hazard

The hazard is missing labeling on the product. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show American Regent, Inc. has 6 other recalls on record since May 13, 2024. Recent recalls include an August 11, 2026 epinephrine injection recall for particulate matter risk and a July 24, 2026 cyanocobalamin injection recall for particulate matter hazards. Other recent recalls of similar products include an August 19, 2026 American Health Packaging Buprenorphine Tablets recall for label mix-up hazard, a April 1, 2026 Wells Pharma Fentanyl Citrate Injectable Solution recall for CGMP deviations, and a March 17, 2026 Nephron Albuterol Inhaler recall for illegible label hazard.

How to tell if you have this one

Check for vials labeled 'Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial' with NDC 0517-1045-01 and lots 24159N0C0 (expiring June 30, 2026) or 25193N0C0 (expiring July 31, 2027).

Brand
American Regent
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Label
Look for missing labels on the vial. If the label is incomplete or missing, stop using the product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 20 days after the firm started it.

Apr 16, 2026Firm started the recall
Apr 28, 2026FDA classified it Class III
May 6, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31347-american-regent-levocarnitine-injection-recall-missing-label-hazard">American Regent Levocarnitine Injection Recall: Missing Label Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0494-2026 (April 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0494-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.