Northbrook, IL, United States
Astellas Pharma US Inc. recalls
2 recalls recorded since 2018, most recently on 23 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)1
Ongoing Class I Drugs
- Recall started
- 23 December 2024
- Reason
- Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0211-2025, D-0210-2025
- 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.
- Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Terminated Class II Drugs
- Recall started
- 22 January 2018
- Terminated
- 1 May 2019
- Reason
- Labeling: Label Error on Declared Strength
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0548-2018
- Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.