D-0298-2026Class II

Sato Pharmaceutical Co., Ltd

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-02-04

Distribution

CA and HI

Firm state

N/A

Product quantity

3,640 bottles

Initiated by

Voluntary: Firm initiated

Reason for recall

Failed Disintegration Specifications: above the time expected.

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

Code / lot info

Lot#: PWXT, Exp 1/31/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →