Class IIIOngoing

Levocarnitine Injection recall

FDA recall D-0494-2026 · initiated Apr 16, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Labeling: Missing Label

Details

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
Recalling company: American Regent, Inc.
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Apr 16, 2026
FDA report date: May 6, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0494-2026 ↗

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