FDA Drugs recall ·
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial… recall
- Recall number
- D-0494-2026
- Date
- (initiated April 16, 2026)
- Company / brand
- American Regent, Inc.
6610 New Albany Rd E, New Albany, OH, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 74,040 Single Dose Vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Labeling: Missing Label
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0494-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.