Drug FDA Class II Ongoing Failed specifications

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

Sato Pharmaceutical Co., Ltd Published Feb 4, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Sato Pharmaceutical Co., Ltd or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Disintegration Specifications: above the time expected.

Hazards

Failed Disintegration · primary

Affected products (1)

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

INON ACE · 3,640 bottles

NDC: 49873-402, 49873-402-01

Code info: Lot#: PWXT, Exp 1/31/2027

Affected areas

CaliforniaHawaii

Timeline

Initiated

Dec 19, 2025
Published

Feb 4, 2026

Recall number: D-0298-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.