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Drug FDA Class I Ongoing Failed specifications

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.

Astellas Pharma US Inc. Published Feb 5, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Astellas Pharma US Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Empty Capsules · primary

Affected products (1)

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.

PROGRAF · 14,340 100-count bottles

NDC: 0469-0607, 0469-0617, 0469-0657, 0469-3016, 0469-1230, 0469-1330, 0469-0607-73, 0469-0617-73, 0469-0617-11, 0469-0657-73, 0469-0657-11, 0469-3016-01, 0469-1230-50, 0469-1330-50
Lot codes: 0E3353D
Code info: Lot# 0E3353D, Exp 03/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 23, 2024
  2. Published
    Feb 5, 2025
Recall number
D-0211-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.