FDA Drugs recall ·
INON ACE Antacid tablets (magnesium aluminosilicate… recall
- Recall number
- D-0298-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- Sato Pharmaceutical Inc.
Ahc Building 1-5-27, Tokyo, N/A, Japan - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,640 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Why was it recalled?
Failed Disintegration Specifications: above the time expected.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: PWXT, Exp 1/31/2027
Distribution
CA and HI
States: California Hawaii
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0298-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.