Oxybutynin Chloride Extended-Release Tablets USP 10 mg — Class II drug recall D-0038-2024
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2023-10-11, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0038-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2023-09-21 |
| Classified | 2023-10-04 |
| Reported by FDA | 2023-10-11 |
| Terminated | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 7,248 bottles |
| Reason classes | specification failure |
| NDC | 68382-0255, 68382-0255-01, 68382-0255-05, 68382-0255-06, 68382-0255-14, 68382-0255-16, 68382-0255-30, 68382-0255-77, 68382-0256, 68382-0256-01, 68382-0256-05, 68382-0256-06, 68382-0256-14, 68382-0256-16, 68382-0256-30, 68382-0256-77, 68382-0257, 68382-0257-01, 68382-0257-05, 68382-0257-06, 68382-0257-14, 68382-0257-16, 68382-0257-30, 68382-0257-77 |
| Lot numbers | M300651, M300652 |
| Expiration dates | 2024-12-20 |
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
Reason for recall
Failed Dissolution Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0038-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.