Pitavastatin Calcium Tablet, Film Coated
FDA Recall NDC 72603-480
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pitavastatin Calcium (NDC 72603-480). A significant event, classified as Class III, was initiated on Feb 03, 2026 by Northstar Rxllc. The reported reason for this action was: "Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Feb 03, 2026
Mar 25, 2026
770 bottles
Recall Profile & Regulatory Data
Event ID
98543
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Annora Pharma Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Product Description
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.
Batch or Lot Expiration Information
Lot# : A252487, Exp 05/31/2027
Affected Packages Involved in this Recall
72603-479-01Product
72603-480-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
