Pitavastatin Tablet, Film Coated
FDA Recall NDC 42291-906
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pitavastatin (NDC 42291-906). A significant event, classified as Class III, was initiated on Jun 26, 2025 by Avkare. The reported reason for this action was: "Failed Impurity/Degradation Specifications"
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
Failed Impurity/Degradation Specifications
Jun 26, 2025
Jul 09, 2025
8,573 bottles
Recall Profile & Regulatory Data
Event ID
97160
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Affected Packages Involved in this Recall
42291-906-90Product
42291-907-90Product
42291-905-90Product
Class III Ongoing
Failed Impurity/Degradation Specifications
Jun 26, 2025
Jul 09, 2025
1,560 bottles
Recall Profile & Regulatory Data
Event ID
97160
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026
Affected Packages Involved in this Recall
42291-906-90Product
42291-907-90Product
42291-905-90Product
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.
