Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, R...
FDA Drug Recall #D-0494-2026 — Class III — April 16, 2026
Recall Summary
| Recall Number | D-0494-2026 |
| Classification | Class III — Low risk |
| Date Initiated | April 16, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Regent, Inc. |
| Location | New Albany, OH |
| Product Type | Drugs |
| 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
Lot / Code Information
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Other Recalls from American Regent, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0398-2025 | Class II | niCARdipine Hydrochloride Injection, USP, 25 mg... | Apr 18, 2025 |
| D-0399-2025 | Class II | niCARdipine Hydrochloride Injection, USP, 25 mg... | Apr 18, 2025 |
| D-0080-2025 | Class II | Venofer (iron sucrose) Injection, USP 100 mg El... | Nov 11, 2024 |
| D-0081-2025 | Class II | Venofer (iron sucrose) Injection, USP 50 mg Ele... | Nov 11, 2024 |
| D-0082-2025 | Class II | Venofer (iron sucrose) Injection, USP 100 mg El... | Nov 11, 2024 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.