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American Regent, Inc.

Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

  • Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Low risk Filed 2026-05-06

Labeling: Missing Label

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

Check these codes: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027

74,040 Single Dose Vials · distributed u.s. nationwide Recall D-0494-2026 on FDA.gov ↗
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