Recalling firm
Sato Pharmaceutical Co., Ltd
Product type
Drug
Status
Ongoing
Report date
2026-02-04
Distribution
CA and HI
Firm state
N/A
Product quantity
3,640 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Failed Disintegration Specifications: above the time expected.
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
Code / lot info
Lot#: PWXT, Exp 1/31/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.