American Regent, Inc.: Levocarnitine Injection, Usp

American Regent, Inc. is recalling Levocarnitine Injection, USP (1 g/5 mL vials) distributed nationwide because some vials are missing their labels. This medication is used intravenously and requires a prescription. The recall affects vials with NDC number 0517-1045-01 that were distributed across all U.S. states and Washington, D.C.

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/6f3da8ef-cbcd-48d6-bc30-dc445f3d064f