Antacid Tablets Recalled Due to Failed Disintegration Specifications

Key Takeaways

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of INON ACE Antacid Tablets (magnesium aluminosilicate, magnesium hydroxide, simethicone), involving 3640 bottles distributed in California and Hawaii, identified as Batch PWXT with an expiration date of January 31, 2027.
• The recall was initiated by Sato Pharmaceutical Co., Ltd. after the product failed disintegration specifications, exceeding the expected time for breakdown—a quality issue that may delay symptom relief but is not likely to cause serious adverse effects.
• INON ACE Antacid Tablets are over-the-counter gastrointestinal agents used to relieve acid indigestion, gas, and heartburn, commonly administered in outpatient and retail settings.

The US Food and Drug Administration (FDA) has issued a Class II recall for INON ACE Antacid Tablets (magnesium aluminosilicate, magnesium hydroxide, and simethicone), packaged in 75-count bottles, due to disintegration failure beyond expected limits. The affected product, manufactured by Sato Pharmaceutical Co., Ltd. in Tokyo, Japan, is labeled under NDC 49873-402-01. The recall involves 3,640 bottles from Lot #PWXT, with an expiration date of January 31, 2027. The recall was initiated on December 19, 2025, and applies to products distributed in California and Hawaii.

The recall was officially classified as Class II by the FDA on January 27, 2026. This classification is issued when use of a product may cause temporary or medically reversible adverse health consequences, with a low risk of serious injury. The tablets’ failure to disintegrate within expected timeframes may delay onset of action, leading to reduced symptom relief or therapeutic variability. The recall was initiated voluntarily by Sato Pharmaceutical, and notification was provided to consignees via letter. No public press release has been issued to date.

INON ACE Antacid Tablets are over-the-counter gastrointestinal agents used for the relief of symptoms associated with acid indigestion, gas, and heartburn. The active ingredients function by neutralizing stomach acid and reducing gas formation. Pharmacists should verify inventory for Lot #PWXT, remove affected bottles, and provide alternative antacid products as needed. Although the quality issue is not expected to cause harm, maintaining consistent disintegration and bioavailability is essential to ensure timely symptom relief for patients.

Reference
FDA. Enforcement Report. January 28, 2026. Accessed January 29, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm