Sato Pharmaceutical Recalls INON ACE Antacid Tablets Due to Disintegration Failure
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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 ↗
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