Recalls / Class II
Class IID-0038-2024
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
- Brand name
- Oxybutynin
- Generic name
- Oxybutynin
- Active ingredient
- Oxybutynin Chloride
- Route
- Oral
- NDCs
- 68382-255, 68382-256, 68382-257
- FDA application
- ANDA202332
- Affected lot / code info
- Lot#: M300652 and M300651, exp. Dec 2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 7,248 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-09-21
- FDA classified
- 2023-10-04
- Posted by FDA
- 2023-10-11
- Terminated
- 2025-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0038-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.