CLASS III Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Livalo (pitavatstatin) tablets, 4 mg recalled
Kowa Pharmaceuticals America is recalling Livalo (pitavatstatin) tablets, 4 mg, distributed in Ohio, Pennsylvania, Texas. The recall was initiated on 24 Feb 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0258-2025
- FDA event ID
- 96379
- Recalling firm
- Kowa Pharmaceuticals America, Montgomery, AL
- Brand
- Livalo
- Manufacturer
- Kowa Pharmaceuticals America, Inc.
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 24 Feb 2025
- FDA classified
- 7 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
Timeline
| 24 Feb 2025 | Recall initiated by company | |
| 7 Mar 2025 | Classified by FDA | +11 days |
| 19 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablets/capsules
Product as listed by the FDA
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
Where it was distributed
PA, OH, and TX
Questions about this recall
Why was it recalled?
Presence of foreign tablets/capsules
Which lots are affected?
Lot#: 3231300, Exp 8/2027
Where was it sold?
PA, OH, and TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Pitavastatin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by Annora Pharma PrivatePitavastatin Calcium | Annora Pharma Private | Packaging Defects | TN |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by Orient Pharma Co., Ltd.Pitavastatin | Orient Pharma Co. Ltd. Yunlin Plant | Potency & Assay | NJ |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Pitavastatin Tablets, 1 mg recalled by Orient Pharma Co., Ltd.Pitavastatin | Orient Pharma Co. Ltd. Yunlin Plant | Potency & Assay | NJ |
| Drug | CLASS III | Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |