Recalling firm
Astellas Pharma US Inc.
Product type
Drug
Status
Ongoing
Report date
2025-02-05
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
14,340 100-count bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Product description
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.
Code / lot info
Lot# 0E3353D, Exp 03/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.