Recalls / Class I
Class ID-0210-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Astagraf Xl
- Generic name
- Tacrolimus Extended-release Capsules
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 0469-0647, 0469-0677, 0469-0687
- FDA application
- NDA204096
- Affected lot / code info
- Lot# 0R3092A, EXP 03/31/2026
Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Recalling firm
- Firm
- Astellas Pharma US Inc.
- Manufacturer
- Astellas Pharma US, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2375 Waterview Dr, Northbrook, Illinois 60062-6145
Distribution
- Quantity
- 3,500 30-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-12-23
- FDA classified
- 2025-01-29
- Posted by FDA
- 2025-02-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0210-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.