Astellas Pharma US Inc. drug recall: Astagraf XL
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96008
- Recall initiated
- Dec 23, 2024
- Classified by FDA
- Jan 29, 2025
- Posted in Enforcement Report
- Feb 5, 2025
- Recalling firm
- Astellas Pharma US Inc.
- Firm location
- Northbrook, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Press Release
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 23, 2024. FDA classified it 37 days later, on Jan 29, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide in the USA Astellas Pharma US Inc. has 4 recalls in our records.
Recalled products (2)
D-0210-2025 Class I Ongoing
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.
Codes / lots: Lot# 0R3092A, EXP 03/31/2026
Quantity: 3,500 30-count bottles
D-0211-2025 Class I Ongoing
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.
Codes / lots: Lot# 0E3353D, Exp 03/31/2026
Quantity: 14,340 100-count bottles
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96008
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.