FDA Drug recall D-0096-2024
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India
- FDA Drug
- Class II
- completed
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0096-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-10-19 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Reason
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Identifiers
| ndc | 68382-255-06 |
|---|---|
| ndc | 68382-255-14 |
| ndc | 68382-255-16 |
| ndc | 68382-255-01 |
| ndc | 68382-255-05 |
| ndc | 68382-255-30 |
| ndc | 68382-255-77 |
| ndc | 68382-256-14 |
| ndc | 68382-256-01 |
| ndc | 68382-256-16 |
| ndc | 68382-256-05 |
| ndc | 68382-256-30 |
| ndc | 68382-256-77 |
| ndc | 68382-256-06 |
| ndc | 68382-257-14 |
| ndc | 68382-257-01 |
| ndc | 68382-257-16 |
| ndc | 68382-257-05 |
| ndc | 68382-257-30 |
| ndc | 68382-257-77 |
| ndc | 68382-257-06 |
| code_info | M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.