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Drug FDA Class III Ongoing Mislabeling

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. Published May 6, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact American Regent, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Labeling: Missing Label

Affected products (1)

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

LEVOCARNITINE · 74,040 Single Dose Vials

NDC: 0517-1045, 0517-1075, 0517-1045-01, 0517-1045-05, 0517-1075-01
Lot codes: 24159N0C0, 25193N0C0
Code info: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 16, 2026
  2. Published
    May 6, 2026
Recall number
D-0494-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.