Recalls / Class II
Class IID-0298-2026
Product
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
- Brand name
- Inon Ace
- Generic name
- Magnesium Aluminosilicates, Magnesium Hydroxide, Simethicone
- Active ingredients
- Dimethicone, Magnesium Hydroxide, Silodrate
- Route
- Oral
- NDC
- 49873-402
- FDA application
- M001
- Affected lot / code info
- Lot#: PWXT, Exp 1/31/2027
Why it was recalled
Failed Disintegration Specifications: above the time expected.
Recalling firm
- Firm
- Sato Pharmaceutical Co., Ltd
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Ahc Building 1-5-27, N/A, Tokyo, N/A N/A, Japan
Distribution
- Quantity
- 3,640 bottles
- Distribution pattern
- CA and HI
Timeline
- Recall initiated
- 2025-12-19
- FDA classified
- 2026-01-27
- Posted by FDA
- 2026-02-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0298-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.