FDAFDA · Food and drugs·Recall number D-0038-2024
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
Published October 11, 2023 · Recall initiated: September 21, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA.
- Lot
- Lot#: M300652 and M300651, exp. Dec 2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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