FDA recall D-0298-2026

Product

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.

Distribution

CA and HI

Key facts

Status

Ongoing

Initiation date

2025-12-19

Report date

2026-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tokyo, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0298-2026