D-0298-2026 Class II Ongoing
FDA drug recall D-0298-2026 was initiated by Sato Pharmaceutical Co., Ltd on December 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
- February 4, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- 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