Oxybutynin Chloride Tablet, Extended Release
FDA Recall NDC 62175-271

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 Oxybutynin Chloride (NDC 62175-271). A significant event, classified as Class III, was initiated on Feb 21, 2019 by Lannett Company, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0996-2019TERMINATED

February 2019 Class III Recall: Failed Dissolution Specifications

Recall Number
D-0996-2019
Class III Terminated
Reason for Recall
Failed Dissolution Specifications
Initiated
Feb 21, 2019
Reported
Mar 20, 2019
Quantity
14,448 bottles

Recall Profile & Regulatory Data

Event ID
82144
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
N/A
Distribution Pattern
Nationwide, including Puerto Rico.
Termination Date
Nov 06, 2020
Product Description
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Batch or Lot Expiration Information
Lot# Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
Affected Packages Involved in this Recall
62175-270-37Product
62175-270-41Product
62175-271-37Product
62175-271-41Product
62175-272-37Product
62175-272-41Product

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.