Limited official informationFDA Drug Enforcement ReportsRecall date: May 6, 2026

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley,...

Full official 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

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

NDC 0517-1045-01
Lot 24159N0C0
Lot 25193N0C0

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
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-...	Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027	74,040 Single Dose Vials	D-0494-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Labeling: Missing Label

Agency classification: Class III

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative
openFDA Drug authoritative

Official scope

Distribution reported by the agency

U.S. Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.