Recall: D-0211-2025

Class I - Dangerous

Class IClassification

2024-12-23Initiated

OngoingStatus

Astellas Pharma US Inc.Firm

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.

Reason

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.