Drug recall
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan…
FDA recall event 96008 · Class I · Astellas Pharma US Inc.
Key facts
| Event ID | 96008 |
|---|---|
| Recall numbers | D-0210-2025, D-0211-2025 |
| Recalling firm | Astellas Pharma US Inc. |
| Product type | Drugs |
| Products | 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., 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. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules |
| Initiation date | Dec 23, 2024 |
| Report date | Feb 5, 2025 |
| City | Northbrook |
| State | IL |
| Country | United States |
| FEI number | 1000036852 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: