FDA Drug recall D-1116-2015
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only by Valeant Pharmaceuticals North America, citing failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1116-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-17 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Identifiers
| code_info | Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/1…Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16. |
|---|
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-1116-2015%22
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