Livalo (pitavatstatin) tablets recall
FDA recall D-0258-2025 · initiated Feb 24, 2025
Kowa Pharmaceuticals America recalled Livalo (pitavatstatin) tablets in Feb 2025 — an FDA Class III recall (D-0258-2025) because Presence of foreign tablets/capsules.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of foreign tablets/capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,328 Bottles
Details
- 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
- Recalling company
- Kowa Pharmaceuticals America
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- PA, OH, and TX
- Initiated
- Feb 24, 2025
- FDA report date
- Mar 19, 2025
This recall is linked to a product we cover: Livalo →
Frequently asked
- Was Livalo (pitavatstatin) tablets recalled?
- Kowa Pharmaceuticals America recalled Livalo (pitavatstatin) tablets in Feb 2025 — an FDA Class III recall (D-0258-2025) because Presence of foreign tablets/capsules. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Livalo (pitavatstatin) tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0258-2025 was: Presence of foreign tablets/capsules
- Is a recalled Livalo (pitavatstatin) tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Livalo (pitavatstatin) tablets are affected?
- Distributed: PA, OH, and TX. The recall covers these lots — Lot#: 3231300, Exp 8/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0258-2025.