HIGHFDA DRUG

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
June 4, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 4, 2026
Hazard Level
HIGH
Brand
Haleon US Holdings
Geographic Scope
1 states

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
Haleon US Holdings
Model numbers
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028, b) X78N, Exp. Date 30Nov2028.
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 4, 2026

  2. Reported by FDA DRUG

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Press Release

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Full Description

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.. Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.. Classification: Class I. Quantity: 35,883 boxes/carton. Distribution: Nationwide within the United States

Safety Guide

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

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lots: a) TL8K
YH9X
YH9Y
Exp. Date. 30Nov2028
b) X78N
+1 more
Affected States
ALL
Report Date
June 17, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE