Sato Pharmaceutical Recalls INON ACE Antacid Tablets Due to Disintegration Failure

What Happened

Sato Pharmaceutical Co., Ltd. has initiated a voluntary recall of INON ACE antacid tablets. The recall was issued after the product failed disintegration specifications, with the tablets taking longer to break down than the expected time requirements. This Class II recall was officially classified by the FDA on January 27, 2026.

Which Products Are Affected

The recall involves 3,640 bottles of INON ACE Antacid tablets. The affected products were distributed in California and Hawaii. Specific identification details include:

• Product Name: INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide, and simethicone)
• Packaging: 75-count bottle
• NDC Number: 49873-402-01
• UPC: 0349873402017
• Lot Number: PWXT
• Expiration Date: 1/31/2027

What You Should Do

Consumers who have purchased the affected lot of INON ACE should stop using the product. Sato Pharmaceutical Co., Ltd. initiated the notification process via letter. Consumers with questions regarding the recall or seeking information on returns should contact the manufacturer, Sato Pharmaceutical Co., Ltd., which is headquartered in Tokyo, Japan.

Why This Matters

When a medication fails disintegration specifications, it may not dissolve properly in the digestive system. This can impact the drug’s effectiveness and how the active ingredients are absorbed by the body.

Source

Information provided by the FDA under recall number D-0298-2026.