Class III · Lower riskActive recall
Levocarnitine
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Missing Label
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmerican Regent, Inc.
| Brand name | LEVOCARNITINE |
| Generic name | LEVOCARNITINE |
| Active ingredient(s) | LEVOCARNITINE |
| Distributed by / for | American Regent, Inc. |
| NDC | 0517-1045-01 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | American Regent, Inc. |
| Distribution | U.S. Nationwide |
| Quantity | 74,040 Single Dose Vials |
| Recall initiated | 2026-04-16 |
| Report date | 2026-05-06 |
| Recall completed | — |
| Recall number | D-0494-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | New Albany OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.