Oxybutynin Chloride Extended-Release Tablets USP 10 mg recall: Failed Dissolution
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
Why was Oxybutynin Chloride Extended-Release Tablets USP 10 mg recalled?
Failed Dissolution Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: M300652 and M300651, exp. Dec 2024
- 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
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 7,248 bottles
- Distribution
- Nationwide in the USA.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)