# FDA recall D-0298-2026

> **Sato Pharmaceutical Co., Ltd** · Class II · drug recall initiated 2025-12-19.

## Product

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

## Reason for recall

Failed Disintegration Specifications: above the time expected.

## Distribution

CA and HI

## Key facts

- **Recall number:** D-0298-2026
- **Recalling firm:** Sato Pharmaceutical Co., Ltd
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tokyo, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0298-2026

## Citation

> AI Analytics. FDA recall D-0298-2026. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0298-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*