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CLASS I · SeriousFDA

Haleon US Holdings LLC recalls Gas-X Extra Strength

📅 Jun 4, 2026 · 📍 Nationwide
Recalling company
Haleon US Holdings LLC
Product
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 – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Jun 4, 2026
Reported
Jun 17, 2026
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
35,883 boxes/carton
Lot / codes
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Company location
Warren, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0595-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0595-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.