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Drug FDA Class III Completed Foreign material

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, congr

Kowa Pharmaceuticals America Published Mar 19, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 25/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Kowa Pharmaceuticals America or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of foreign tablets/capsules

Hazards

Foreign Tablets/Capsules · primary

Affected products (1)

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

LIVALO · 5,328 Bottles

NDC: 66869-104, 66869-204, 66869-404, 66869-104-90, 66869-204-90, 66869-204-07, 66869-404-90, 66869-404-07
Code info: Lot#: 3231300, Exp 8/2027

Affected areas

OhioPennsylvaniaTexas

Timeline

  1. Initiated
    Feb 24, 2025
  2. Published
    Mar 19, 2025
Recall number
D-0258-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.