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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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