Food, drugs, devices › Shionogi Inc.
Drug recall: Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bott
FDA enforcement event 71828 is a drug recall by Shionogi Inc. of Alpharetta, GA, initiated 24 Jul 2015 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 31% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Apr 2016. Initiation: voluntary: firm initiated. Shionogi Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Shionogi Inc., Alpharetta, GA.
Reason for recall
"Failed Dissolution Specifications"
Distribution
"Nationwide and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1284-2015 | 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… | a) 483 bottles; b) 5,631 bottles | Class III | Terminated | 12 Aug 2015 |
Context
Other enforcement events for Shionogi Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 May 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Man | Drug | Class III | 1 |
| 24 May 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 450 | Drug | Class III | 2 |
| 8 Mar 2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45 | Drug | Class II | 1 |
All 4 events for Shionogi Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specifications"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.