FDA Class III Recall Issued for Pitavastatin Tablets Due to Mixed Dosage Tablet in Bottle

A Class III recall has been issued for pitavastatin tablets, 2 mg, packaged in 90-count bottles (NDC 72603-479-01), according to the latest US Food and Drug Administration (FDA) Enforcement Report. The affected product, manufactured by Annora Pharma Pvt. Ltd in Telangana, India, and distributed by Northstar Rx LLC in Memphis, Tennessee, involves 770 bottles from lot A252487 with an expiration date of May 31, 2027. Distribution has been limited to Tennessee. The recall, identified as number D-0391-2026, remains ongoing.

The recall has been classified as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences but may still pose a quality concern. This action was voluntarily initiated by the firm on February 3, 2026, with notification to consignees carried out via letter. The FDA officially classified the recall on March 16, 2026. No press release has been issued.

The reason for the recall is the presence of foreign tablets/capsules, specifically the discovery of one 1 mg pitavastatin tablet inside a bottle labeled as containing 2 mg tablets. Such mix-ups can lead to dosing inconsistencies, which are particularly relevant in lipid-lowering therapy where dose precision is important. Pitavastatin is indicated as an HMG-CoA reductase inhibitor (statin) used to reduce elevated total cholesterol, ow-density lipoprotein (LDL) cholesterol, triglycerides, and to increase high-density lipoprotein (HDL) cholesterol in patients with hyperlipidemia, helping lower the risk of cardiovascular disease.

Reference

FDA. Enforcement Report. March 16, 2026. Accessed March 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219033