# FDA recall D-0038-2024

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2023-09-21.

## 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

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0038-2024
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-09-21
- **Report date:** 2023-10-11
- **Termination date:** 2025-08-06

- **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-0038-2024

## Citation

> AI Analytics. FDA recall D-0038-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0038-2024. Source: US FDA. Licensed CC0.

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