FDAClass IFebruary 5, 2025

Prograf recall

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.

Why was Prograf recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 0E3353D, Exp 03/31/2026

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.
Recalling firm
Astellas Pharma US Inc.
Quantity
14,340 100-count bottles
Distribution
Nationwide in the USA
Recall date
February 5, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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