Class I — UrgentReported 2025-02-05

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.

Reason for Recall

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

Recall Number

D-0211-2025

Classification

Class I

Status

Ongoing