D-0298-2026 Class II Ongoing
FDA drug recall D-0298-2026 was initiated by Sato Pharmaceutical Co., Ltd on Dec 19, 2025 and is designated Class II. Reason for recall: Failed Disintegration Specifications: above the time expected. The recall status is ongoing. Affected quantity: 3,640 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 4, 2026
- Initiation Date
- Dec 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,640 bottles
Product description
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Reason for recall
Failed Disintegration Specifications: above the time expected.
Distribution pattern
CA and HI
Code information
Lot#: PWXT, Exp 1/31/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0298-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026