Class II · Moderate risk
Lipo MIC + L-Carnitine for Injection
Lack of Assurance of Sterility
Levocarnitine Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Missing Label
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was 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
Affected NDC
0517-1045-01
Compare with the code on your package — it is the most precise check available.
Drug: Carnitine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levocarnitine NDC 00517-1045 |
200 mg/mL | Injection, Solution Intravenous |
American Regent, Inc. | Rx |
- Recalling firm
- American Regent, Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0494-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Carnitine recalls
See all
Class II · Moderate risk
L-Carnitine for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
L-Carnitine 500 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL
Lack of Assurance of Sterility
Other recalls by American Regent, Inc.
All 2026 recalls
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Tralement (trace elements injection 4*, USP)
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
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