September 2023 FDA Recall Oxybutynin by Zydus Pharmaceuticals (usa) Inc (D-0038-2024 - Failed Dissolution Specifications)
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on September 21, 2023 for the product Oxybutynin. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0038-2024
Failed Dissolution Specifications
09-21-2023
10-11-2023
7,248 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
08-06-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
