FDA Recall D-0211-2025

Astellas Pharma US Inc. · Northbrook, IL

Class I — life-threatening Ongoing 507 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: Lot# 0E3353D, Exp 03/31/2026

Quantity: 14,340 100-count bottles

Reason for recall

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

Recall record

Recall number: D-0211-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2024-12-23
Classified by FDA Center: 2025-01-29
FDA published: 2025-02-05
Recalling firm: Astellas Pharma US Inc.
Firm location: Northbrook, IL

Drug identification

Brand name(s): PROGRAF
Generic name(s): TACROLIMUS
Manufacturer(s): Astellas Pharma US, Inc.
NDC(s): 0469-0607, 0469-0617, 0469-0657, 0469-3016, 0469-1230, 0469-1330
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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