Recall archive / FDA drug enforcement
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactu... — FDA record D-0298-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
- Reason
- Failed Disintegration Specifications: above the time expected.
- Classification
- Class II
- Recalling firm
- Sato Pharmaceutical Co., Ltd
- Quantity
- 3,640 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0298-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot#: PWXT, Exp 1/31/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CA and HI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 4, 2026
- Recall initiation date
- Dec 19, 2025
- Center classification date
- Jan 27, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.