Sato Pharmaceutical Co., Ltd: Drug Recall
Recall #D-0298-2026 · 12/19/2025
Class II: Risk
Recall Details
- Recall Number
- D-0298-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Sato Pharmaceutical Co., Ltd
- Status
- Ongoing
- Date Initiated
- 12/19/2025
- Location
- Tokyo, N/A, Japan
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,640 bottles
Reason for Recall
Failed Disintegration Specifications: above the time expected.
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
Distribution Pattern
CA and HI
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.