Levocarnitine Injection recall (American Regent, Inc.)
DrugClass IIIOngoing
Summary: American Regent, Inc. is recalling 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. Reason: Labeling: Missing Label.
What is being 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. NDC: 0517-1045-01
Why
Labeling: Missing Label
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0494-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | April 16, 2026 |
| Reported | May 6, 2026 |
| Company | American Regent, Inc. |
| Company location | New Albany, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 74,040 Single Dose Vials |
More recalls from American Regent, Inc. · all drug recalls · recalls from April 2026