Nisoldipine Extended Release Tablets — Class III drug recall D-1284-2015
Terminated recall by Shionogi Inc., reported 2015-08-12, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1284-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shionogi Inc., Alpharetta, GA, United States |
| Recall initiated | 2015-07-24 |
| Classified | 2015-08-04 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-04-14 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00359630501105 |
| NDC | 59630-0501-10, 66993-0472, 66993-0472-02, 66993-0473, 66993-0473-02, 66993-0475, 66993-0475-02 |
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 for recall
Failed Dissolution Specifications
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-1284-2015. 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.