FDAClass III · Drug · Recall D-0494-2026 · Recalled May 6, 2026
Levocarnitine Injection recall — American Regent, Inc.
Agency report date: May 6, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Labeling: Missing Label
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class III: not likely to cause adverse health consequences.
Affected product: Levocarnitine Injection recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More American Regent recalls
- Epinephrine Injection recall — American Regent, Inc.FDA · September 16, 2026
- Papaverine HCl Injection recall — American Regent, Inc.FDA · August 26, 2026
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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 4, 2026 at 11:00 PM UTC.