# FDA recall D-822-2013

> **Warner Chilcott US LLC** · Class II · drug recall initiated 2013-05-17.

## Product

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet.  Physician Sample 7 Tablets bottle, Rx only,  Mfd by:  Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07

## Reason for recall

Failed Impurities/Degradation Specifications: unspecified degradation product

## Distribution

Nationwide

## Key facts

- **Recall number:** D-822-2013
- **Recalling firm:** Warner Chilcott US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-17
- **Report date:** 2013-08-07
- **Termination date:** 2015-11-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-822-2013

## Citation

> AI Analytics. FDA recall D-822-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-822-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*