Oxybutynin Tablet, Film Coated, Extended Release
FDA Recall NDC 68382-255
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Oxybutynin (NDC 68382-255). A significant event, classified as Class II, was initiated on Oct 19, 2023 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point."
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
October 2023 Class II Recall: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall Number
Class II Completed
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oct 19, 2023
Nov 15, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93260
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Batch or Lot Expiration Information
Lot# M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024
Affected Packages Involved in this Recall
68382-255-06Product
68382-255-14Product
68382-255-16Product
68382-255-01Product
68382-255-05Product
68382-255-30Product
68382-255-77Product
68382-256-14Product
68382-256-01Product
68382-256-16Product
68382-256-05Product
68382-256-30Product
68382-256-77Product
68382-256-06Product
68382-257-14Product
68382-257-01Product
68382-257-16Product
68382-257-05Product
68382-257-30Product
68382-257-77Product
68382-257-06Product
October 2023 Class II Recall: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall Number
Class II Completed
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oct 19, 2023
Nov 15, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93260
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Batch or Lot Expiration Information
Lot# M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Affected Packages Involved in this Recall
68382-255-06Product
68382-255-14Product
68382-255-16Product
68382-255-01Product
68382-255-05Product
68382-255-30Product
68382-255-77Product
68382-256-14Product
68382-256-01Product
68382-256-16Product
68382-256-05Product
68382-256-30Product
68382-256-77Product
68382-256-06Product
68382-257-14Product
68382-257-01Product
68382-257-16Product
68382-257-05Product
68382-257-30Product
68382-257-77Product
68382-257-06Product
October 2023 Class II Recall: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall Number
Class II Completed
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oct 19, 2023
Nov 15, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93260
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Batch or Lot Expiration Information
Lot# M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024
Affected Packages Involved in this Recall
68382-255-06Product
68382-255-14Product
68382-255-16Product
68382-255-01Product
68382-255-05Product
68382-255-30Product
68382-255-77Product
68382-256-14Product
68382-256-01Product
68382-256-16Product
68382-256-05Product
68382-256-30Product
68382-256-77Product
68382-256-06Product
68382-257-14Product
68382-257-01Product
68382-257-16Product
68382-257-05Product
68382-257-30Product
68382-257-77Product
68382-257-06Product
Class II Terminated
Failed Dissolution Specifications
Sep 21, 2023
Oct 11, 2023
7,248 bottles
Recall Profile & Regulatory Data
Event ID
93100
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Aug 06, 2025
Product Description
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Batch or Lot Expiration Information
Lot# : M300652 and M300651, exp. Dec 2024
Affected Packages Involved in this Recall
68382-255-06Product
68382-255-14Product
68382-255-16Product
68382-255-01Product
68382-255-05Product
68382-255-30Product
68382-255-77Product
68382-256-14Product
68382-256-01Product
68382-256-16Product
68382-256-05Product
68382-256-30Product
68382-256-77Product
68382-256-06Product
68382-257-14Product
68382-257-01Product
68382-257-16Product
68382-257-05Product
68382-257-30Product
68382-257-77Product
68382-257-06Product
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.
