INON ACE Antacid tablets (magnesium aluminosilicate recall
FDA recall D-0298-2026 · initiated Dec 19, 2025
Sato Pharmaceutical Co., Ltd recalled INON ACE Antacid tablets (magnesium aluminosilicate in Dec 2025 — an FDA Class II recall (D-0298-2026) because Failed Disintegration Specifications: above the time expected.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Disintegration Specifications: above the time expected.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,640 bottles
Details
- Product
- INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
- Recalling company
- Sato Pharmaceutical Co., Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- CA and HI
- Initiated
- Dec 19, 2025
- FDA report date
- Feb 4, 2026
Frequently asked
- Was INON ACE Antacid tablets (magnesium aluminosilicate recalled?
- Sato Pharmaceutical Co., Ltd recalled INON ACE Antacid tablets (magnesium aluminosilicate in Dec 2025 — an FDA Class II recall (D-0298-2026) because Failed Disintegration Specifications: above the time expected. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was INON ACE Antacid tablets (magnesium aluminosilicate recalled?
- Per the FDA enforcement record, the reason for recall D-0298-2026 was: Failed Disintegration Specifications: above the time expected.
- Is a recalled INON ACE Antacid tablets (magnesium aluminosilicate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of INON ACE Antacid tablets (magnesium aluminosilicate are affected?
- Distributed: CA and HI. The recall covers these lots — Lot#: PWXT, Exp 1/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0298-2026.