Multi event Drug Recall Enforcement Report Class I voluntary initiated by Astellas Pharma US Inc., originally initiated on 12-23-2024 for the product Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. The product was recalled due to failed tablet/capsule specifications: bottles shipped to the usa may contain empty capsules. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0210-2025 | 12-23-2024 | 02-05-2025 | Class I | 3,500 30-count bottles | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Ongoing |
| D-0211-2025 | 12-23-2024 | 02-05-2025 | Class I | 14,340 100-count bottles | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0469-0607 | Prograf | Tacrolimus | Capsule, Gelatin Coated | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-0617 | Prograf | Tacrolimus | Capsule, Gelatin Coated | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-0647 | Astagraf Xl | Tacrolimus Extended-release Capsules | Capsule, Coated, Extended Release | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-0657 | Prograf | Tacrolimus | Capsule, Gelatin Coated | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-0677 | Astagraf Xl | Tacrolimus Extended-release Capsules | Capsule, Coated, Extended Release | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-0687 | Astagraf Xl | Tacrolimus Extended-release Capsules | Capsule, Coated, Extended Release | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-1230 | Prograf | Tacrolimus | Granule, For Suspension | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-1330 | Prograf | Tacrolimus | Granule, For Suspension | Oral | Astellas Pharma Us, Inc. | Human Prescription Drug |
| 0469-3016 | Prograf | Tacrolimus | Injection, Solution | Intravenous | Astellas Pharma Us, Inc. | Human Prescription Drug |
