HIGHFDA DRUG

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 19, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 19, 2025
Hazard Level
HIGH
Brands
INON ACE, Sato Pharmaceutical Co., Ltd.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
2 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
INON ACE, Sato Pharmaceutical Co., Ltd.
Product type
Antacid Tablets
Model numbers
Lot#: PWXT, Exp 1/31/2027
UPC codes
49873-402, 49873-402-01
Sold at
Multiple Retailers
Where affected
CA, HI

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 19, 2025

  2. Reported by FDA DRUG

    February 4, 2026

  3. RecallRadar source check

    February 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Failed Disintegration Specifications: above the time expected.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Sato Pharmaceutical Co., Ltd or your healthcare provider for guidance. Notification method: Letter

About This Product

INON ACE Antacid tablets are designed to provide relief from symptoms of heartburn and indigestion. Consumers typically purchase antacids for quick relief from gastrointestinal discomfort.

Why This Is Dangerous

The recall stems from the product failing to meet disintegration specifications, which means the tablets may not dissolve as intended in the digestive system. This can lead to inadequate symptom relief for users.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers relying on these antacid tablets may experience a lack of effective relief from symptoms, potentially leading to discomfort or worsening of symptoms.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product label.
  2. Confirm the expiration date is January 31, 2027.
  3. Stop using the product if it matches the recalled lot number.

Where to find product info

The lot number and expiration date can usually be found on the bottom or side of the bottle label.

What timeline to expect

Expect a refund process to take about 4-6 weeks after contacting the manufacturer.

If the manufacturer is unresponsive

  • Document all correspondence with the company.
  • Follow up with a second contact if no response is received within a week.
  • Consider filing a complaint with the FDA if the issue persists.

How to prevent similar issues

  • Look for FDA recall alerts when purchasing medications.
  • Choose products that have clear labeling and certification.
  • Consult with a healthcare provider for recommendations on safe antacid options.

Documentation advice

Keep a record of your purchase receipt and any correspondence with the manufacturer regarding the recall.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall affects INON ACE Antacid tablets in 75-count bottles, manufactured by Sato Pharmaceutical Co., Ltd. The affected lot number is PWXT, with an expiration date of January 31, 2027. The product was distributed in California and Hawaii.

Key Facts

  • Recall date: December 19, 2025
  • Report date: February 4, 2026
  • Quantity recalled: 3,640 bottles
  • Distribution states: California, Hawaii

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot#: PWXT
Exp 1/31/2027
UPC Codes
49873-402
49873-402-01
Affected States
CA, HI
Report Date
February 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
MEDIUM

Taro Pharmaceuticals Withdraws Diclofenac Sodium Gel Over Viscosity Issues

Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.

BEEKEEPER'S NATURALS USA
Microbial Contamination
Read more
Health & Personal Care
MEDIUM

AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues

AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.

SUN PHARMACEUTICAL INDUSTRIES
Labeling: Not
Read more