Irbesartan Tablet
FDA Recall NDC 50268-441
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 Irbesartan (NDC 50268-441). A significant event, classified as Class II, was initiated on Jan 21, 2025 by Avpak. The reported reason for this action was: "Out of Specification for Dissolution"
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 II Ongoing
Out of Specification for Dissolution
Jan 21, 2025
Feb 19, 2025
341 cartons
Recall Profile & Regulatory Data
Event ID
96172
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Batch or Lot Expiration Information
Lot# Lot 45279, Exp 03/31/2025
Affected Packages Involved in this Recall
50268-440-11Product
50268-440-15Product
50268-441-11Product
50268-441-15Product
50268-442-11Product
50268-442-15Product
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.
