FDA recall, , Low risk
American Regent Levocarnitine Injection
Levocarnitine Injection is missing its label.
Summary by Recall Canary from the FDA notice
What happened
American Regent, Inc., of New Albany, Ohio, recalled 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, because the labeling is missing the label. The U.S. Food and Drug Administration reported the recall began April 16, 2026, and was added to its Enforcement Report on April 28, 2026. The product was distributed nationwide in the U.S. The recall affected 74,040 single-dose vials.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 0517-1045-01
- Lot code
- 24159N0C0
- 25193N0C0
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- American Regent, Inc.New Albany, Ohio
- Hazard
- Labeling error
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98787
- Recall number
- D-0494-2026
- Quantity recalled
- 74,040 Single Dose Vials
All recalls from American Regent, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
