Class I

Drug Recall: 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.

Astellas Pharma US Inc. · December 23, 2024

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

14,340 100-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0211-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.