Haleon Us Holdings Llc: Gas-x Extra Strength, Simethicone 125 Mg/antigas

Recall Summary Gas-X Extra Strength Simethicone 125 mg is being recalled nationwide due to contamination with a diluted propylene glycol-based coolant that leaked from packaging equipment. The recall affects two package sizes: 120-count and 72-count softgels sold by Haleon. This is a Class I recall, the most serious classification, affecting consumers across all U.S. states and Washington, D.C.

Recalling firm
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
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-06-04
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/a5b4e8b3-7488-4768-8ba9-9e05944a66d5