FindMyRecallSubscribe
Class III: unlikely to cause harmOngoing

American Regent Levocarnitine Injection Recall

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intraven…

American Regent, Inc. · New Albany, OH

Risk level
Class III
Reported by FDA
May 6, 2026
Recall ID
D-0494-2026
Check your lot numberHow we source this data

Summary

American Regent recalled Levocarnitine Injection starting Apr 16, 2026. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0494-2026 on May 6, 2026. Reason: Labeling: Missing Label. Status: Ongoing.

Why it was recalled

Labeling: Missing Label

Product description

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

Lot numbers, UPCs & expiration codes

Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0494-2026
Classification
Class III
Status
Ongoing
Recall initiated
Apr 16, 2026
FDA report date
May 6, 2026
Quantity
74,040 Single Dose Vials
Recall type
Voluntary: Firm initiated
Recalling firm
American Regent, Inc.

Original FDA data

Every field from FDA enforcement report D-0494-2026, exactly as published.

Show all FDA fields
City
New Albany
State
OH
Status
Ongoing
Country
United States
Event ID
98787
Address
6610 New Albany Rd E
Code information
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Postal code
43054-8730
Report date
May 6, 2026
Product type
Drugs
Recall number
D-0494-2026
Classification
Class III
Recalling firm
American Regent, Inc.
Product quantity
74,040 Single Dose Vials
Reason for recall
Labeling: Missing Label
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
U.S. Nationwide
Recall initiation date
Apr 16, 2026
Initial firm notification
Letter
Center classification date
Apr 28, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0494-2026, published May 6, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls