FDAClass III · Drug · Recalled May 6, 2026

Levocarnitine Injection recall — American Regent, Inc.

Hazard: Labeling: Missing Label

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0494-2026
Brand: American Regent
Classification: Class III
Units affected: 74,040 Single Dose Vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Levocarnitine Injection

Companies & origin

Recalling firm location: New Albany, OH, United States
Firm address: 6610 New Albany Rd E, 43054-8730

Identifying details (verbatim from the notice)

Product codes / lots: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Distribution: U.S. Nationwide
Firm notified the public via: Letter
FDA event ID: 98787
Recall initiated: April 16, 2026
FDA classified: April 28, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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