Inon Ace Tablet
FDA Recall NDC 49873-402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Inon Ace (NDC 49873-402). A significant event, classified as Class II, was initiated on Dec 19, 2025 by Sato Pharmaceutical Co., Ltd.. The reported reason for this action was: "Failed Disintegration Specifications: above the time expected."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Disintegration Specifications: above the time expected.
Dec 19, 2025
Feb 04, 2026
3,640 bottles
Recall Profile & Regulatory Data
Event ID
98216
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sato Pharmaceutical Co., Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
CA and HI
Product Description
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Batch or Lot Expiration Information
Lot# : PWXT, Exp 1/31/2027
Affected Packages Involved in this Recall
49873-402-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
