Astellas Pharma US Inc. recalls Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma
Recalled February 5, 2025 · FDA recall D-0211-2025 · Astellas Pharma US
Hazard
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules · FDA Class I
Units
14,340 100-count bottles
Sold at
Nationwide in the USA
Description
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Product
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.
Manufacturer(s)
Astellas Pharma US Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →