Drug recall
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle…
FDA recall event 98216 · Class II · Sato Pharmaceutical Co., Ltd
Key facts
| Event ID | 98216 |
|---|---|
| Recall numbers | D-0298-2026 |
| Recalling firm | Sato Pharmaceutical Co., Ltd |
| Product type | Drugs |
| Products | INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Disintegration Specifications: above the time expected. |
| Initiation date | Dec 19, 2025 |
| Report date | Feb 4, 2026 |
| City | Tokyo |
| Country | Japan |
| FEI number | 1000421090 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: