Warning
Sato Pharmaceutical Co. Recalls INON ACE Antacid tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0298-2026Drug / Pharmaceutical
Sato Pharmaceutical Co. Recalls INON ACE Antacid tablets
Sato Pharmaceutical Co., Ltd · Class II — Moderate Risk
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
Reason for Recall
Failed Disintegration Specifications: above the time expected.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
CA and HI
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Sato Pharmaceutical Co., Ltd, initiated on December 19, 2025. Failed Disintegration Specifications: above the time expected. This recall covers 3,640 bottles, distributed in CA and HI. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.