← FDA ENFORCEMENT
D-0494-2026Class III

American Regent, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-05-06
Distribution
U.S. Nationwide
Firm state
OH
Product quantity
74,040 Single Dose Vials
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →