Prograf — Class I drug recall D-0211-2025
Ongoing recall by Astellas Pharma US Inc., reported 2025-02-05, distributed nationwide. Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
| Recall number | D-0211-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astellas Pharma US Inc., Northbrook, IL, United States |
| Recall initiated | 2024-12-23 |
| Classified | 2025-01-29 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| NDC | 00469-0607, 00469-0607-73, 00469-0617, 00469-0617-11, 00469-0617-73, 00469-0657, 00469-0657-11, 00469-0657-73, 00469-1230, 00469-1230-50, 00469-1330, 00469-1330-50, 00469-3016, 00469-3016-01 |
| Lot numbers | 0E3353D |
| Expiration dates | 2026-03-31 |
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.
Reason for recall
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0211-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.