FDA Recall D-0494-2026

American Regent, Inc. · New Albany, OH

Class III Ongoing 28 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027

Quantity: 74,040 Single Dose Vials

Reason for recall

Labeling: Missing Label

Recall record

Recall number: D-0494-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2026-04-16
Classified by FDA Center: 2026-04-28
FDA published: 2026-05-06
Recalling firm: American Regent, Inc.
Firm location: New Albany, OH

Drug identification

Brand name(s): LEVOCARNITINE
Generic name(s): LEVOCARNITINE
Manufacturer(s): American Regent, Inc.
NDC(s): 0517-1045, 0517-1075
Route(s): INTRAVENOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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