December 2025 FDA Recall Inon Ace by Sato Pharmaceutical Co., Ltd
D-0298-2026 - Failed Disintegration Specifications

This Class II drug recall was voluntarily initiated by Sato Pharmaceutical Co., Ltd on December 19, 2025 for the product Inon Ace. The FDA reported the reason for recall as failed disintegration specifications. The product was distributed in CA and HI and the recall is currently ongoing.

Recall Number: D-0298-2026

Reason for Recall
Failed Disintegration Specifications: above the time expected.
Initiated
12-19-2025
Reported
02-04-2026
Quantity
3,640 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98216
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sato Pharmaceutical Co., Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA and HI
Product Description About Product Description
Full technical description of the product.
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

49873-402-01 Inon Ace