Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

Recall Number: D-0211-2025

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

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.