Class IOngoing

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recall

FDA recall D-0210-2025 · initiated Dec 23, 2024

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

Product: 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.
Recalling company: Astellas
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Dec 23, 2024
FDA report date: Feb 5, 2025

This recall is linked to a product we cover: Astagraf XL →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0210-2025 ↗

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