American Regent, Inc.
American Regent, Inc. appears in FDA public data with 8 recalls, 0 510(k) clearances, 36 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0494-2026, Class III) was initiated on April 16, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 36
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0494-2026 | Class III | Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx O | April 16, 2026 |
| D-0399-2025 | Class II | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, | April 18, 2025 |
| D-0398-2025 | Class II | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, | April 18, 2025 |
| D-0081-2025 | Class II | Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose | November 11, 2024 |
| D-0082-2025 | Class II | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vi | November 11, 2024 |
| D-0080-2025 | Class II | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vi | November 11, 2024 |
| D-0503-2024 | Class II | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx | May 14, 2024 |
| D-0507-2024 | Class II | Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only | May 13, 2024 |