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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
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 23, 2026 at 11:04 PM UTC.
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