PITAVASTATIN CALCIUM
Recalling Firm / Manufacturer: Annora Pharma Private Limited
(Hyderabad, India)
FDA Recall Number: D-0391-2026
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 CALCIUM
Generic Name
PITAVASTATIN CALCIUM
Active Substance(s)
Pitavastatin Calcium
Administration Route
Oral
National Drug Code (NDC)
72603-479
Total Quantity Recalled
770 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Full Product Description
Packaging specifications and labeling details
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
March 25, 2026
Firm Initiation Date
February 03, 2026
FDA Classification Date
Mar 16, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: A252487, Exp 05/31/2027
Distribution Information
Geographic scope of affected shipments
TN
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-0391-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC