FDAClass IIIMay 6, 2026

Levocarnitine Injection recall: Labeling Error

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.…

Why was Levocarnitine Injection recalled?

Labeling: Missing Label

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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.…
Recalling firm
American Regent, Inc.
Quantity
74,040 Single Dose Vials
Distribution
U.S. Nationwide
Recall date
May 6, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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