It's said 86 million Americans have high cholesterol. Here's an important heads-up for statin users in two U.S. regions.
More Than 5,000 Bottles of a Cholesterol Medication Recalled in 3 States
Published on Mar. 10, 2025
Statins are one of the most common, and most trusted, treatments to help manage high cholesterol. Research is also increasingly nodding to other statin benefits, some even related to cancer—and all this is why a recent recall announcement could pique patients’ attention.
On Friday, the U.S. Food and Drug Administration (FDA) updated a recall for 5,328 total bottles of Livalo, a brand name for the drug pitavatstatin. The Livalo website says the drug is indicated “for adults with high cholesterol that, along with a heart-healthy diet, helps to lower ‘bad’ cholesterol (LDL-C).”
The “presence of foreign tablets/capsules” is the listed reason for the recall, which may suggest the bottles contain incorrect tablets or dosages inside. Originally announced February 24, the recall has been listed as a Class III event. This is reassuring—it’s the FDA’s manner of determining that the products are “unlikely to cause health problems but fail to comply with FDA labeling or manufacturing regulations.”
The recalled product information is as follows, with the recalled product reportedly distributed to Pennsylvania, Ohio, and Texas:
- Livalo (pitavatstatin) tablets, 4 milligrams (mg)
- 90-count bottles, only available via prescription
- Lot #: 3231300
- Expiration Date: 8/2027
- 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
Data from the Centers for Disease Control and Prevention (CDC) suggests 86 million American adults have total cholesterol levels that are considered to be high—but only 54.5% of people who likely should be taking medication for cholesterol actually are.
If you believe you have the affected medication on hand, reach out to your doctor or pharmacist for advice or a replacement. Consumers may also report any adverse health effects to the FDA’s MedWatch Adverse Event Reporting Program.
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