FDA Drug recall D-1284-2015
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-1…
- FDA Drug
- Class III
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class III recall of Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-1… by Shionogi, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1284-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-24 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shionogi |
| Distribution | US |
Product
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
Reason
Failed Dissolution Specifications
Identifiers
| upc | 359630501105 |
|---|---|
| upc | 36693473024 |
| ndc | 66993-472-02 |
| ndc | 66993-473-02 |
| ndc | 66993-475-02 |
| ndc | 59630-501-10 |
| code_info | Lot #: a) 8803472, Exp 03/16; b) 8803473, Exp 03/16 |
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-1284-2015%22
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