Astagraf XL 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.
Why was Astagraf XL recalled?
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 0R3092A, EXP 03/31/2026
- 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 date
- February 5, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)