FDA Drug · D-0494-2026

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

Class III · Ongoing

Labeling: Missing Label

Affected lots / codes — check yours against thisLot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027

Recalling firm: American Regent, Inc., New Albany, OH
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 74,040 Single Dose Vials
Distribution: U.S. Nationwide
Recall initiated: April 16, 2026
Classified: April 28, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0494-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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