Prograf Capsule, Gelatin Coated
FDA Recall NDC 0469-0607
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Prograf (NDC 0469-0607). A significant event, classified as Class I, was initiated on Dec 23, 2024 by Astellas Pharma Us, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Dec 23, 2024
Feb 05, 2025
14,340 100-count bottles
Recall Profile & Regulatory Data
Event ID
96008
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Astellas Pharma US Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# 0E3353D, Exp 03/31/2026
Affected Packages Involved in this Recall
0469-0607-73Product
0469-0617-73Product
0469-0617-11Product
0469-0657-73Product
0469-0657-11Product
0469-3016-01Product
0469-1230-50Product
0469-1330-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
