Levocarnitine Injection recall
FDA recall D-0494-2026 · initiated Apr 16, 2026
American Regent, Inc. recalled Levocarnitine Injection in Apr 2026 — an FDA Class III recall (D-0494-2026) because Labeling: Missing Label.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Missing Label
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 74,040 Single Dose Vials
Details
- Product
- 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 company
- American Regent, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Apr 16, 2026
- FDA report date
- May 6, 2026
Frequently asked
- Was Levocarnitine Injection recalled?
- American Regent, Inc. recalled Levocarnitine Injection in Apr 2026 — an FDA Class III recall (D-0494-2026) because Labeling: Missing Label. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Levocarnitine Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0494-2026 was: Labeling: Missing Label
- Is a recalled Levocarnitine Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Levocarnitine Injection are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0494-2026.