FDA Drug recall D-0258-2025
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc
- FDA Drug
- Class III
- completed
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class III recall of Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc by Kowa Pharmaceuticals America, citing presence of foreign tablets/capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0258-2025 |
| Classification | Class III |
| Status | completed |
| Initiated | 2025-02-24 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kowa Pharmaceuticals America |
| Distribution | OH, PA, TX |
Product
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case
Reason
Presence of foreign tablets/capsules
Identifiers
| ndc | 66869-104-90 |
|---|---|
| ndc | 66869-204-90 |
| ndc | 66869-204-07 |
| ndc | 66869-404-90 |
| ndc | 66869-404-07 |
| code_info | Lot#: 3231300, Exp 8/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0258-2025%22
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