Recalls / Class I
Class ID-0211-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Prograf
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 0469-0607, 0469-0617, 0469-0657, 0469-3016, 0469-1230, 0469-1330
- FDA application
- NDA050708
- Affected lot / code info
- Lot# 0E3353D, Exp 03/31/2026
Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Recalling firm
- Firm
- Astellas Pharma US Inc.
- Manufacturer
- Astellas Pharma US, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2375 Waterview Dr, Northbrook, Illinois 60062-6145
Distribution
- Quantity
- 14,340 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-12-23
- FDA classified
- 2025-01-29
- Posted by FDA
- 2025-02-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0211-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.