CLASS II ONGOING Drug recall · Reported 4 Feb 2026 · FDA Enforcement Report
INON ACE Antacid tablets (magnesium aluminosilicate recalled
Sato Pharmaceutical is recalling INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), distributed in California, Hawaii. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0298-2026
- FDA event ID
- 98216
- Recalling firm
- Sato Pharmaceutical, Tokyo, N/A
- Brand
- Inon Ace
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2025
- FDA classified
- 27 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 19 Dec 2025 | Recall initiated by company | |
| 27 Jan 2026 | Classified by FDA | +39 days |
| 4 Feb 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Disintegration Specifications: above the time expected.
Product as listed by the FDA
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Where it was distributed
CA and HI
Questions about this recall
Why was it recalled?
Failed Disintegration Specifications: above the time expected.
Which lots are affected?
Lot#: PWXT, Exp 1/31/2027
Where was it sold?
CA and HI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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