Venlafaxine Tablet, Extended Release
FDA Recall NDC 43598-944
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 Venlafaxine (NDC 43598-944). A significant event, classified as Class III, was initiated on Jan 16, 2025 by Dr. Reddy's Laboratories Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Jan 16, 2025
Jan 29, 2025
1380 bottles
Recall Profile & Regulatory Data
Event ID
96128
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Appco Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA.
Product Description
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Batch or Lot Expiration Information
Lot# : 2402101UR, Exp 02/28/2027
Affected Packages Involved in this Recall
43598-943-30Product
43598-943-90Product
43598-944-30Product
43598-944-90Product
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.
