FDA Drug recall D-822-2013
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet
- FDA Drug
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet by Warner Chilcott Us, citing failed Impurities/Degradation Specifications: unspecified degradation product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-822-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-17 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Warner Chilcott Us |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: unspecified degradation product
Identifiers
| code_info | Lot F1002 - Exp.12/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-822-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.