Class I
Ongoing
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.
This recall is currently active, issued February 5, 2025. It was issued by Astellas Pharma Us Inc.
- Company
- Astellas Pharma Us Inc
- Recall Initiated
- December 23, 2024
- Posted
- February 5, 2025
- Recall Number
- D-0211-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,340 100-count bottles
- Firm Location
- Northbrook, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Distribution
Nationwide in the USA
Lot / Code Info
Lot# 0E3353D, Exp 03/31/2026
More recalls by Astellas Pharma Us Inc
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Phar...
Feb 14, 2018 · Class II
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025