FDA Drugs recall ·
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0211-2025
- Date
- (initiated December 23, 2024)
- Company / brand
- Astellas Pharma US Inc.
2375 Waterview Dr, Northbrook, IL, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 14,340 100-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 0E3353D, Exp 03/31/2026
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0211-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.