Moderate riskFDA DrugClass II

INON ACE antacid tablets recalled for failed disintegration

Some bottles of INON ACE antacid tablets are dissolving more slowly than they should in your stomach. This means the medication may not work as intended. The affected bottles were distributed in California and Hawaii.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have INON ACE antacid tablets, lot #PWXT with expiration date 1/31/2027
  2. Stop taking tablets from this lot
  3. Consult your pharmacist or doctor about a replacement antacid

Is yours affected?

Compare your label or packaging with the recalled product.

Product
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Sold in
CA and HI
Made for
Adults

Details

Units affected
3,640 bottles
Illnesses reported
None reported
Manufactured in
Ahc Building 1-5-27, N/A, Tokyo, N/A, Japan
Classification
Class II
Recall number
D-0298-2026

In the FDA's words

Description
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 Failed Disintegration Specifications: above the time expected. Lot#: PWXT, Exp 1/31/2027 Distribution: CA and HI Affected quantity: 3,640 bottles
Hazard
Failed Disintegration Specifications: above the time expected.

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