Nifedipine Extended-Release Tablets — Class II drug recall D-1116-2015
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2015-06-17, distributed nationwide. Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
| Recall number | D-1116-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-04-17 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 93,237 bottles |
| Reason classes | specification failure |
| NDC | 00093-2059-01 |
| Lot numbers | 02/16, 04/16, 10/15, 11/15, 1309T27, 1309T28, 1311T33, 1311T34, 1312T40, 1312T41, 1403T21, 1403T23, 1405T21, 1405T22, 8/15 |
Product
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Reason for recall
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
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-1116-2015. 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.