High risk Drugs & MedicationsClass I

Gas-X Extra Strength Simethicone 125 mg Recall

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), Di

Updated June 4, 2026

Gas-X Extra Strength Simethicone 125 mg softgels have been recalled because a machine leak during packaging may have contaminated the capsules with a diluted propylene glycol-based coolant. Ingesting a chemical coolant poses a serious health risk, making this a Class I recall.

Is the Haleon US Holdings LLC recalled? Yes. This product was recalled by FDA on June 4, 2026. Details below.

What is recalled

Gas-X Extra Strength, Simethicone 125 mg Antigas Softgels, distributed by Haleon, Warren, NJ 07059, in two package sizes: (a) 120 SoftGels, UPC 3 00674 35041 9; (b) 72 SoftGels, UPC 3 00439 00572 1.

Am I affected

You're affected if you have Gas-X Extra Strength Simethicone 125 mg softgels at home in either of these package sizes: the 120-count with UPC 3 00674 35041 9, or the 72-count with UPC 3 00439 00572 1. Check the barcode on the bottom or back of your package against those numbers.

What to do right now

Stop using this product immediately. This is a firm-initiated recall, so contact Haleon or the retailer where you purchased it for guidance on a refund or replacement. If you have already taken capsules from the affected lot and feel unwell, contact your doctor or pharmacist. For more information, visit the FDA recall page at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

The hazard

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

Brands affected

Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0595-2026
Classification
Class I
Recalled
June 4, 2026
Read the official notice

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