Enablex — Class II drug recall D-822-2013
Terminated recall by Warner Chilcott US LLC, reported 2013-08-07, distributed nationwide. Failed Impurities/Degradation Specifications: unspecified degradation product
| Recall number | D-822-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Warner Chilcott US LLC, Rockaway, NJ, United States |
| Recall initiated | 2013-05-17 |
| Classified | 2013-07-26 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2015-11-30 |
| Distributed | Nationwide (US) |
| Quantity | 188,600 bottles |
| Reason classes | specification failure |
| NDC | 00078-9420-07 |
| Lot numbers | 12/13, F1002 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-822-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.