Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Enablex (darifenacin) Extended Release Tablet Recalled by Warner Chilcott US LLC Due to Failed Impurities/Degradation Specifications: unspecified degradation product

Date: May 17, 2013
Company: Warner Chilcott US LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Warner Chilcott US LLC directly.

Affected Products

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

Quantity: 188,600 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: unspecified degradation product

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Warner Chilcott US LLC

Warner Chilcott US LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report