Home / Recalls / American Regent, Inc. / D-0494-2026

D-0494-2026 Class III Ongoing

Recalled by American Regent, Inc. — New Albany, OH

Recall Details

Product Type
Drugs
Report Date
May 6, 2026
Initiation Date
April 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
74,040 Single Dose Vials

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

Reason for Recall

Labeling: Missing Label

Distribution Pattern

U.S. Nationwide

Code Information

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

Other recalls by American Regent, Inc.

  • D-0398-2025 Class II — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single (April 18, 2025)
  • D-0399-2025 Class II — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single (April 18, 2025)
  • D-0080-2025 Class II — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), (November 11, 2024)
  • D-0082-2025 Class II — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), (November 11, 2024)
  • D-0081-2025 Class II — Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL) (November 11, 2024)
  • D-0503-2024 Class II — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Si (May 14, 2024)
  • D-0507-2024 Class II — Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multipl (May 13, 2024)