PITAVASTATIN
Recalling Firm / Manufacturer: AvKARE
(Pulaski, TN, United States)
FDA Recall Number: D-0529-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
PITAVASTATIN
Generic Name
PITAVASTATIN CALCIUM
Active Substance(s)
Pitavastatin Calcium
Administration Route
Oral
National Drug Code (NDC)
42291-905
Total Quantity Recalled
8,573 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurity/Degradation Specifications
Full Product Description
Packaging specifications and labeling details
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
July 09, 2025
Firm Initiation Date
June 26, 2025
FDA Classification Date
Jul 16, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0529-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC