FDA Recall D-0298-2026
Sato Pharmaceutical Co., Ltd · Tokyo, N/A
Class II Ongoing 146 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Failed Disintegration Specifications: above the time expected.
Recall record
- Recall number
D-0298-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- CA and HI
- Recall initiated
- 2025-12-19
- Classified by FDA Center
- 2026-01-27
- FDA published
- 2026-02-04
- Recalling firm
- Sato Pharmaceutical Co., Ltd
- Firm location
- Tokyo, N/A, Japan
Drug identification
- Brand name(s)
- INON ACE
- Generic name(s)
- MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE
- Manufacturer(s)
- Sato Pharmaceutical Co., Ltd.
- NDC(s)
49873-402- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.