Quick Facts at a Glance
- Recall Date
- April 16, 2026
- Hazard Level
- HIGH
- Brands
- LEVOCARNITINE, American Regent, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LEVOCARNITINE, American Regent, Inc.
- Model numbers
- Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
- UPC codes
- 0517-1045, 0517-1075, 0517-1045-01, 0517-1045-05, 0517-1075-01
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 16, 2026
Reported by FDA DRUG
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Missing Label
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact American Regent, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full 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. Generic: LEVOCARNITINE; Brand: LEVOCARNITINE. Reason: Labeling: Missing Label. Classification: Class III. Quantity: 74,040 Single Dose Vials. Distribution: U.S. Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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