Why it was recalled
Presence of foreign tablets/capsules
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 3231300, Exp 8/2027
Where it was sold
PA, OH, and TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0258-2025
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Feb 24, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 5,328 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kowa Pharmaceuticals America
Original FDA data
Every field from FDA enforcement report D-0258-2025, exactly as published.
Show all FDA fields
- City
- Montgomery
- State
- AL
- Status
- Completed
- Country
- United States
- Event ID
- 96379
- Address
- 530 Industrial Park Blvd
- Code information
- Lot#: 3231300, Exp 8/2027
- Postal code
- 36117-5543
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0258-2025
- Classification
- Class III
- Recalling firm
- Kowa Pharmaceuticals America
- Product quantity
- 5,328 Bottles
- Reason for recall
- Presence of foreign tablets/capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- PA, OH, and TX
- Recall initiation date
- Feb 24, 2025
- Center classification date
- Mar 7, 2025