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.

Recall Number: D-0210-2025

Firm: Astellas Pharma US Inc.

Classification: Class I

Status: Ongoing

Report Date: 20250205

Initiation Date: 20241223

Termination Date:

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

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.