Home / Recalls / Astellas Pharma US Inc. / D-0211-2025

D-0211-2025 Class I Ongoing

Recalled by Astellas Pharma US Inc. — Northbrook, IL

Recall Details

Product Type
Drugs
Report Date
February 5, 2025
Initiation Date
December 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,340 100-count bottles

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 0E3353D, Exp 03/31/2026

Other recalls by Astellas Pharma US Inc.

  • D-0210-2025 Class I — Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX (December 23, 2024)
  • D-0548-2018 Class II — Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Market (January 22, 2018)
  • D-0008-2015 Class II — Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: (September 15, 2014)
  • D-820-2013 Class II — AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, Fo (June 19, 2013)