Astellas Pharma US Inc
Astellas Pharma US Inc appears in FDA public data with 5 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 10 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0211-2025, Class I) was initiated on Dec 23, 2024.
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0211-2025 | Class I | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed | Dec 23, 2024 |
| D-0210-2025 | Class I | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Jap | Dec 23, 2024 |
| D-0548-2018 | Class II | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Phar | Jan 22, 2018 |
| D-0008-2015 | Class II | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharm | Sep 15, 2014 |
| D-820-2013 | Class II | AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusi | Jun 19, 2013 |