FDA recall, , Moderate risk
Sato INON ACE Antacid Tablets
Failed Disintegration Specifications: above the time expected.
Summary by Recall Canary from the FDA notice
What happened
Sato Pharmaceutical Co., Ltd., of Tokyo, Japan, recalled 3,640 bottles of INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, because the product failed disintegration specifications, above the time expected. The recall began December 19, 2025, and was added to the FDA's Enforcement Report on January 27, 2026. The recalled product was distributed in California and Hawaii.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC matches.
An NDC (National Drug Code) is usually printed on the drug's label.
Inon ACE Antacid tablets
- NDC
- 49873-402-01
Recall details
- Company began the recall
- Sold in
- Company
- Sato Pharmaceutical Co., LtdTokyo, Japan
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98216
- Recall number
- D-0298-2026
- Quantity recalled
- 3,640 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
