Pitavastatin Tablets Recalled Due to Foreign Tablet Contamination

Kowa Pharmaceuticals America has issued a voluntary recall of Livalo (pitavastatin) tablets, 4 mg, 90-count bottles due to the presence of foreign tablets or capsules in the product. The affected lot #3231300 (expiration date August 2027) includes 5328 bottles. While no official press release has been issued, the US Food and Drug Administration (FDA) confirms that the recall is ongoing.

The recall was initiated on February 24, 2025, with the FDA classifying it as a Class III recall on March 7, 2025. Class III recalls typically indicate a low risk of serious adverse health consequences. However, the presence of foreign tablets poses a potential risk of medication errors or unintended drug exposure. Livalo is manufactured by Patheon, Inc (USA) and Kowa Company, Ltd (Japan) and marketed by Kowa Pharmaceuticals America in Montgomery, Alabama. The recall affects distribution in Pennsylvania, Ohio, and Texas.

Livalo (pitavastatin) is a prescription statin medication used to lower cholesterol levels and reduce the risk of cardiovascular disease. It works by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol production. Pharmacists in affected regions should review inventory, remove recalled products, and advise patients accordingly. While no public notification has been issued, pharmacies should stay informed and follow standard recall procedures.