American Regent recalls Levocarnitine Injection vials with missing labels. This labeling issue may lead to incorrect use. Contact the manufacturer for details.
Labeling: Missing Label
American Regent is recalling Levocarnitine Injection vials due to missing labels. This could cause incorrect use of the medication, especially since it's a prescription drug for intravenous use.
The vials lack proper labeling, which could lead to incorrect dosing or administration. Since this is a prescription drug used intravenously, missing labels might cause serious errors if not addressed.
Prescription patients using this medication for intravenous use. Healthcare providers who administer the drug are most at risk.
Check for vials labeled 'Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial' with NDC 0517-1045-01 and lots 24159N0C0 (expiring June 30, 2026) or 25193N0C0 (expiring July 31, 2027).
Look for missing labels on the vial. If the label is incomplete or missing, stop using the product.
The product is not safe to use if the label is missing. Always check the label before use.
Check for vials with NDC 0517-1045-01 and lots 24159N0C0 (expiring June 30, 2026) or 25193N0C0 (expiring July 31, 2027).
If the label is missing, stop using the product. Contact American Regent for further instructions.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0494-2026 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0494-2026 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
