INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured
Summary
The FDA issued a Class II for INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and sim by Sato Pharmaceutical Co., Ltd. Reason: Failed Disintegration Specifications: above the time expected..
Details
Source
Drug Recall
External ID
D-0298-2026
Action Date
2026-02-04
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: PWXT, Exp 1/31/2027
Quantity Affected: 3,640 bottles
Reason for Recall
Failed Disintegration Specifications: above the time expected.
Distribution
CA and HI
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Tokyo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sato Pharmaceutical Co., Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sato Pharmaceutical Co., Ltd have FDA actions?
This is the only FDA action we have on record for Sato Pharmaceutical Co., Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0298-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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