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CLASS II · ModerateFDA

Sato Pharmaceutical Co., Ltd recalls INON ACE Antacid tablets

📅 Dec 19, 2025 · 📍 CA, HI
Recalling company
Sato Pharmaceutical Co., Ltd
Product
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 19, 2025
Reported
Feb 4, 2026
Distribution
CA and HI
Status
Ongoing
Quantity
3,640 bottles
Lot / codes
Lot#: PWXT, Exp 1/31/2027
Company location
Tokyo, N/A
Recall type
Voluntary: Firm initiated
Recall number
D-0298-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0298-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.