Reported Feb 5, 2025 · Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:…
Astellas Pharma US Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Astellas Pharma US Inc. · 2375 Waterview Dr · Northbrook, IL · 60062-6145
Is this the product you have?
- Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan
- Distributed byAstellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73
- Lot codes and dates
Lot# 0R3092AEXP 03/31/2026
- Amount recalled
- 3,500 30-count bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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