MedicineWatch US
Class I Recall

Astellas Pharma US Inc.

Product
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
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Classification
Class I
Status
Ongoing
Lot
Lot# 0E3353D, Exp 03/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Astellas Pharma US Inc. — Class I Recall | MedicineWatch US