# FDA recall D-0097-2024

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2023-10-19.

## 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.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0097-2024
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-10-19
- **Report date:** 2023-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pennington, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2024

## Citation

> AI Analytics. FDA recall D-0097-2024. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0097-2024. Source: US FDA. Licensed CC0.

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