INON ACE Antacid tablets recall (Sato Pharmaceutical Co., Ltd)
DrugClass IIOngoing
Summary: Sato Pharmaceutical Co., Ltd is recalling INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01. Reason: Failed Disintegration Specifications: above the time expected.
What is being recalled
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Why
Failed Disintegration Specifications: above the time expected.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
CA and HI (states named: California, Hawaii)
How to tell if yours is affected
Lot#: PWXT, Exp 1/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0298-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 19, 2025 |
| Reported | February 4, 2026 |
| Company | Sato Pharmaceutical Co., Ltd |
| Company location | Tokyo, N/A, Japan |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,640 bottles |
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