Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of ...
FDA Recall #D-0210-2025 — Class I — December 23, 2024
Product Description
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Recalling Firm
Astellas Pharma US Inc. — Northbrook, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
3,500 30-count bottles
Distribution
Nationwide in the USA
Code Information
Lot# 0R3092A, EXP 03/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated