Recall: 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

This page indexes a United States Food and Drug Administration (FDA) enforcement report describing a drug recall associated with American Regent, Inc.. The recalled item is described in the source record as 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. The FDA assigned this recall a regulatory classification of Class III, and the recall is currently recorded with a status of Ongoing. The recall is identified in FDA systems by recall number D-0494-2026. The recalling firm is associated with OH, United States in the source record. This recall record was published on 2026-05-06. Every field on this page is reproduced as a regulatory data point from the official openFDA dataset and is intended to help you locate and verify the original report. It is not a safety instruction, a clinical assessment, or advice about whether to use any product. Confirm all details against the linked FDA source before relying on them.

FDA recall data

Recall number	D-0494-2026
Event ID	98787
Classification	Class III (least serious regulatory tier)
Status	Ongoing
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
Recalling firm	American Regent, Inc.
Distribution pattern	U.S. Nationwide
State	OH
Country	United States
Report date	2026-05-06
Recall initiation date	2026-04-16

Reason for recall (source data field)

The following text is the recalling firm's stated reason, reproduced verbatim from the FDA enforcement report as a regulatory data field. It is presented for identification and verification only — it is not a safety instruction, a clinical assessment, or advice.

Labeling: Missing Label

How to interpret this recall record

A recall record means a firm has removed or corrected a marketed product in cooperation with the FDA, and that the agency has logged the action in its enforcement reports. The classification (Class III) is the FDA's regulatory severity tier for the action; it describes the agency's assessment of the recall event in administrative terms, not a personalised risk statement for any individual. The status (Ongoing) reflects where the recall sits in its lifecycle. Read this entry as a pointer to an official report: open the linked FDA source to confirm the product, lot scope, dates, and current status before acting on any of it.

What this record does not mean

This recall record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

Related manufacturer

This recall is attributed to American Regent, Inc.. That page aggregates the firm's other indexed recall and shortage records as coverage-limited regulatory signals (not quality ratings).

Related recalls (Class III)

Source & provenance

Official source: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2026%22
Source dataset: openFDA Drug Enforcement API
Publication date: 2026-05-06
Ingested: 2026-06-09
Record hash: b675f09940c656a7

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.