Astellas Pharma US Inc.: Drug Recall

Recall #D-0210-2025 · 12/23/2024

Class I: Dangerous

Recall Details

Recall Number
D-0210-2025
Classification
Class I
Product Type
Drug
Recalling Firm
Astellas Pharma US Inc.
Status
Ongoing
Date Initiated
12/23/2024
Location
Northbrook, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,500 30-count bottles

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.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.