FDA Drug recall D-0211-2025
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbro…
- FDA Drug
- Class I
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class I recall of Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbro… by Astellas Pharma Us, citing failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0211-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-23 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Astellas Pharma Us |
| Distribution | US |
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
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Identifiers
| ndc | 0469-0607-73 |
|---|---|
| ndc | 0469-0617-73 |
| ndc | 0469-0617-11 |
| ndc | 0469-0657-73 |
| ndc | 0469-0657-11 |
| ndc | 0469-3016-01 |
| ndc | 0469-1230-50 |
| ndc | 0469-1330-50 |
| code_info | Lot# 0E3353D, Exp 03/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0211-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.