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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Levocarnitine Injection Recalled for Missing Labeling

Agency Publication Date: April 28, 2026
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Summary

American Regent, Inc. is recalling 74,040 vials of Levocarnitine Injection, USP (200 mg/mL), a prescription medication used to treat carnitine deficiency. The recall was initiated because some vials are missing their product labels entirely. Without a label, the medication cannot be identified, which may lead to administration errors or using the wrong drug. No incidents or injuries have been reported to date.

Risk

A missing label prevents healthcare providers from identifying the drug, strength, and expiration date, potentially resulting in a patient receiving the wrong medication or an incorrect dose.

What You Should Do

  1. Stop using the recalled Levocarnitine Injection vials immediately.
  2. Identify affected products by checking for Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vials with NDC 0517-1045-01.
  3. Check the vial or carton for lot number 24159N0C0 (Exp. June 30, 2026) or lot number 25193N0C0 (Exp. July 31, 2027).
  4. Contact the manufacturer, American Regent, Inc., or your distributor to arrange for the return of the recalled product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Levocarnitine Injection, USP (1 g/5 mL)by American Regent, Inc.
Variants: 200 mg/mL, 5 mL Single-Dose Vial, Intravenous use, Rx Only
Lot Numbers:
24159N0C0 (Exp. June 30, 2026)
25193N0C0 (Exp. July 31, 2027)
NDC:
0517-1045-01

Recalled due to missing labeling on some vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98787
Status: Active
Manufacturer: American Regent, Inc.
Sold By: wholesalers; distributors
Manufactured In: United States
Units Affected: 74,040
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.