Shionogi Inc.
Complete recall history across all FDA and CPSC categories — 5 total recalls
Shionogi Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (5)
FDA drug safety enforcement actions by Shionogi Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 24, 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... | Failed Dissolution Specifications: Low dissolution results were obtained duri... | Class III |
| May 24, 2017 | Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... | Presence of foreign substance: The recall was initiated due to black particle... | Class III |
| May 24, 2017 | PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... | Failed Dissolution Specifications: Low dissolution results were obtained duri... | Class III |
| Jul 24, 2015 | Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipi... | Failed Dissolution Specifications | Class III |
| Mar 8, 2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manuf... | Failed USP Dissolution Test Requirements: Out of Specification dissolution re... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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