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
3,500 30-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
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Code / lot info
Lot# 0R3092A, 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.