INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-cou...
FDA Recall #D-0298-2026 — Class II — December 19, 2025
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.
Recalling Firm
Sato Pharmaceutical Co., Ltd — Tokyo, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,640 bottles
Distribution
CA and HI
Code Information
Lot#: PWXT, Exp 1/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated