FDAFDA · Food and drugs·Recall number D-0210-2025
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.
Published February 5, 2025 · Recall initiated: December 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- ASTAGRAF XL
- Manufacturer
- Astellas Pharma US Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot# 0R3092A, EXP 03/31/2026
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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