Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Prograf (tacrolimus) capsules Recalled by Astellas Pharma US Inc. Due to Failed Tablet/Capsule Specifications: Bottles shipped to the USA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Astellas Pharma US Inc. directly.
Affected Products
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.
Quantity: 14,340 100-count bottles
Why Was This Recalled?
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Astellas Pharma US Inc.
Astellas Pharma US Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report