Sato Pharmaceutical Recalls INON ACE Antacid Tablets Due to Disintegration Failure

Source: FDA · California, Hawaii

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Sato Pharmaceutical Co., Ltd. is voluntarily recalling 3,640 bottles of INON ACE antacid tablets in California and Hawaii because the product failed to meet disintegration time specifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references California, Hawaii. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Sato Pharmaceutical Co., Ltd. has initiated a voluntary recall of INON ACE antacid tablets. The recall was issued after the product failed disintegration specifications, with the tablets taking longer to break down than the expected time requirements. This Class II recall was officially classified by the FDA on January 27, 2026.

Which Products Are Affected

The recall involves 3,640 bottles of INON ACE Antacid tablets. The affected products were distributed in California and Hawaii. Specific identification details include:

  • Product Name: INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide, and simethicone)
  • Packaging: 75-count bottle
  • NDC Number: 49873-402-01
  • UPC: 0349873402017
  • Lot Number: PWXT
  • Expiration Date: 1/31/2027

What You Should Do

Consumers who have purchased the affected lot of INON ACE should stop using the product. Sato Pharmaceutical Co., Ltd. initiated the notification process via letter. Consumers with questions regarding the recall or seeking information on returns should contact the manufacturer, Sato Pharmaceutical Co., Ltd., which is headquartered in Tokyo, Japan.

Why This Matters

When a medication fails disintegration specifications, it may not dissolve properly in the digestive system. This can impact the drug's effectiveness and how the active ingredients are absorbed by the body.

Source

Information provided by the FDA under recall number D-0298-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sato Pharmaceutical Co., Ltd. is voluntarily recalling 3,640 bottles of INON ACE antacid tablets in California and Hawaii because the product failed to meet disintegration time specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects California, Hawaii. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.