Why it was recalled
Failed Disintegration Specifications: above the time expected.
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 numbers, UPCs & expiration codes
Lot#: PWXT, Exp 1/31/2027
Where it was sold
CA and HI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0298-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 19, 2025
- FDA report date
- Feb 4, 2026
- Quantity
- 3,640 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sato Pharmaceutical Co., Ltd
Original FDA data
Every field from FDA enforcement report D-0298-2026, exactly as published.
Show all FDA fields
- City
- Tokyo
- Status
- Ongoing
- Country
- Japan
- Event ID
- 98216
- Address
- Ahc Building 1-5-27
- Code information
- Lot#: PWXT, Exp 1/31/2027
- Report date
- Feb 4, 2026
- Product type
- Drugs
- Recall number
- D-0298-2026
- Classification
- Class II
- Recalling firm
- Sato Pharmaceutical Co., Ltd
- Product quantity
- 3,640 bottles
- Reason for recall
- Failed Disintegration Specifications: above the time expected.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- CA and HI
- Recall initiation date
- Dec 19, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 27, 2026