American Regent, Inc.: Levocarnitine Injection, Usp

American Regent, Inc. is recalling Levocarnitine Injection (a medication given intravenously) because some vials are missing their labels. The product was distributed nationwide across all U.S. states and territories. This recall affects healthcare facilities and providers who may have received vials without proper labeling information.

Recalling firm

American Regent, Inc.

Product

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

Reason

Labeling: Missing Label

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-16

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/d141bc00-c04d-4347-909f-124a5bd3b5da