Critical Alert
Haleon US Holdings LLC Recalls Gas-X Extra Strength
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0595-2026Drug / Pharmaceutical
Haleon US Holdings LLC Recalls Gas-X Extra Strength
Haleon US Holdings LLC · Class I — Most Serious
Product 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 for Recall
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a pharmaceutical product recalled by Haleon US Holdings LLC on June 4, 2026. Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. This recall affects 35,883 boxes/carton and was distributed nationwide. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.