The U.S. Food and Drug Administration (FDA) has updated and expanded a recall involving 5,328 bottles of Livalo, a prescription medication commonly used to treat high cholesterol in adults. The recall, first initiated earlier this year, was revised on Friday to include additional bottles of the drug, which is known generically as pitavastatin.
Livalo, manufactured by Kowa Pharmaceuticals America, is a widely prescribed statin medication intended to help reduce levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad” cholesterol. According to the official Livalo website, the drug is “indicated for adults with high cholesterol that, along with a heart-healthy diet, helps to lower ‘bad’ cholesterol (LDL-C).” Statins like Livalo are typically prescribed to patients at risk of cardiovascular disease, including those who have already experienced heart attacks, strokes, or other related health events.
The reason for the recall, according to FDA documentation, relates primarily to packaging and labeling issues rather than problems with the drug’s chemical formulation or safety profile. The agency’s notice specifies that bottles of Livalo were found to be labeled with incorrect expiration dates, potentially leading to confusion about the drug’s shelf life and safe usage period. While there have been no reported adverse events or injuries directly linked to the mislabeled bottles, the FDA emphasized that ensuring accurate labeling is crucial to maintaining public safety and proper medical adherence.
The updated recall covers 2 mg and 4 mg dosage bottles distributed across multiple states. Pharmacists, healthcare providers, and patients are being advised to check their Livalo bottles carefully and compare them against the lot numbers listed in the FDA’s official recall notice. Any identified bottles affected by the recall should be returned according to the guidance provided by the manufacturer or the dispensing pharmacy.
Patients who are currently taking Livalo and who may have questions about whether their medication is part of the recall are encouraged to contact their pharmacist or prescribing healthcare provider for clarification. The FDA also maintains a publicly accessible database of recalled products on its website, where patients and providers can verify specific lot numbers and expiration dates.
Kowa Pharmaceuticals America has issued a statement in coordination with the FDA, assuring patients and healthcare providers that the company is committed to maintaining the highest standards of product quality and safety. The company also indicated that it is working with distributors and pharmacies to identify and retrieve all affected products.
Although labeling issues are considered a Class II recall — meaning the defect is unlikely to cause serious health problems — both the FDA and Kowa Pharmaceuticals are treating the matter with caution to avoid potential confusion or improper use.
This latest recall highlights ongoing concerns within the pharmaceutical industry about ensuring accuracy in packaging and distribution processes. The FDA continues to monitor the situation and will provide updates if additional actions are required.
For more information on the recall, including a list of affected lot numbers, patients and providers can visit the FDA’s official website or contact Kowa Pharmaceuticals directly.
