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FDA · Drugs ·

Levocarnitine Injection recall

American Regent, Inc. recalled Levocarnitine Injection on May 6, 2026 because of labeling: Missing Label. It was sold nationwide.

Why it was recalled

Labeling: Missing Label

What's recalled

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

Quantity: 74,040 Single Dose Vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
American Regent, Inc., New Albany, OH
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
U.S. Nationwide
Status
Ongoing
Recall number
D-0494-2026
Source
U.S. Food and Drug Administration

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