Warner Chilcott Recalls Enablex Extended Release Tablets Due to Impurities
Warner Chilcott US LLC is recalling 188,600 bottles of Enablex (darifenacin) 15 mg extended-release tablets because they failed impurity specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall without specific reports of hospitalization or death is assigned a score of 4 (Severe).
Plain-English summary
Warner Chilcott US LLC is voluntarily recalling 188,600 bottles of Enablex (darifenacin) Extended Release Tablets, 15 mg. The affected product is the physician sample 7-tablet bottle, NDC 0078-9420-07, manufactured by Novartis Pharma Stein AG. The recall is limited to Lot F1002 with an expiration date of 12/13.
The recall was initiated because the product failed impurities/degradation specifications, specifically due to an unspecified degradation product. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled tablets and contact their healthcare provider or pharmacist for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- Warner Chilcott US LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 188,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot F1002 - Exp.12/13
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08