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

D-0494-2026 Class III Ongoing

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

FDA drug recall D-0494-2026 was initiated by American Regent, Inc. on April 16, 2026 and is designated Class III. Reason for recall: Labeling: Missing Label The recall status is ongoing. Affected quantity: 74,040 Single Dose Vials.

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

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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)