# FDA recall D-0990-2019

> **AVKARE Inc.** · Class III · drug recall initiated 2019-03-01.

## Product

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0990-2019
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-01
- **Report date:** 2019-03-20
- **Termination date:** 2020-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0990-2019

## Citation

> AI Analytics. FDA recall D-0990-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0990-2019. Source: US FDA. Licensed CC0.

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