Astagraf XL 0.5 mg Recall
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.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Astagraf XL 0.5 mg recalled?
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot# 0R3092A, EXP 03/31/2026
- Agency record number
- D-0210-2025
- 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 firm
- Astellas Pharma US Inc.
- Quantity
- 3,500 30-count bottles
- Distribution
- Nationwide in the USA
- Recall started
- December 23, 2024
- Report date
- February 5, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)