FDA Drug recall D-0494-2026
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY…
- FDA Drug
- Class III
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class III recall of 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… by American Regent, citing labeling: Missing Label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0494-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-04-16 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
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. NDC: 0517-1045-01
Reason
Labeling: Missing Label
Identifiers
| ndc | 0517-1045-01 |
|---|---|
| ndc | 0517-1045-05 |
| ndc | 0517-1075-01 |
| code_info | Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by American Regent
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FDA Drug · Class I · 2026-09-16 · American Regent - Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)1…
FDA Drug · Class II · 2026-08-26 · American Regent - Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x…
FDA Drug · Class II · 2026-08-26 · American Regent - Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0…
FDA Drug · Class II · 2026-08-26 · American Regent - Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Via…
FDA Drug · Class I · 2026-08-26 · American Regent
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.