Oxybutynin Chloride Extended-Release Tablet USP — Class II drug recall D-0097-2024
Completed recall by Zydus Pharmaceuticals (USA) Inc, reported 2023-11-15, distributed nationwide. Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 mo
| Recall number | D-0097-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-11-08 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| 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 |
| Expiration dates | 2024-11, 2024-12 |
Product
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Reason for recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
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-0097-2024. 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.