Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Failed Disintegration Specifications: above the time expected.
Consumers and healthcare providers should stop using this product immediately. Contact Sato Pharmaceutical Co., Ltd or your healthcare provider for guidance. Notification method: Letter
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The recall affects INON ACE Antacid tablets in 75-count bottles, manufactured by Sato Pharmaceutical Co., Ltd. The affected lot number is PWXT, with an expiration date of January 31, 2027. The product was distributed in California and Hawaii.
The recall is due to the antacid tablets failing disintegration specifications, which means they may not dissolve in the body as intended. If the tablets do not disintegrate properly, they may not provide the expected relief from symptoms such as heartburn or indigestion.
No injuries or adverse incidents have been reported related to this recall. However, the potential for reduced efficacy raises concerns for consumers relying on these medications.
Consumers should stop using the recalled antacid tablets immediately. Contact Sato Pharmaceutical Co., Ltd. or consult a healthcare provider for further guidance and information on refunds.
For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0298-2026 or reach out to Sato Pharmaceutical Co., Ltd.
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