Livalo — Class III drug recall D-0258-2025
Completed recall by Kowa Pharmaceuticals America, reported 2025-03-19, distributed in OH, PA, TX. Presence of foreign tablets/capsules
| Recall number | D-0258-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kowa Pharmaceuticals America, Montgomery, AL, United States |
| Recall initiated | 2025-02-24 |
| Classified | 2025-03-07 |
| Reported by FDA | 2025-03-19 |
| Distributed | OH, PA, TX |
| Quantity | 5,328 bottles |
| NDC | 66869-0104, 66869-0104-90, 66869-0204, 66869-0204-07, 66869-0204-90, 66869-0404, 66869-0404-07, 66869-0404-90 |
| Lot numbers | 3231300 |
| Expiration dates | 2027-08 |
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 for recall
Presence of foreign tablets/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-0258-2025. 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.