Levocarnitine Injection — Class III drug recall D-0494-2026
Ongoing recall by American Regent, Inc., reported 2026-05-06, distributed nationwide. Labeling: Missing Label
| Recall number | D-0494-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Regent, Inc., New Albany, OH, United States |
| Recall initiated | 2026-04-16 |
| Classified | 2026-04-28 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 74,040 single |
| Reason classes | labeling |
| NDC | 00517-1045, 00517-1045-01, 00517-1045-05, 00517-1075, 00517-1075-01 |
| Lot numbers | 24159N0C0, 25193N0C0 |
| Expiration dates | 2026-06-30, 2027-07-31 |
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 for recall
Labeling: Missing Label
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0494-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.