Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent
Summary
The FDA issued a Class III for Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i by American Regent, Inc.. Reason: Labeling: Missing Label.
Details
Source
Drug Recall
External ID
D-0494-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
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/Code Info: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Quantity Affected: 74,040 Single Dose Vials
Reason for Recall
Labeling: Missing Label
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-16
Company
New Albany, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
American Regent, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Regent, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Regent, Inc. have FDA actions?
American Regent, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0494-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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