Astellas Pharma US Inc. recalls Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:
Recalled February 5, 2025 · FDA recall D-0210-2025 · Astellas Pharma US
Hazard
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules · FDA Class I
Units
3,500 30-count bottles
Sold at
Nationwide in the USA
Description
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
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.
Manufacturer(s)
Astellas Pharma US Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →