Gas-X Extra Strength recall (Haleon US Holdings LLC)
DrugClass IOngoing
Summary: Haleon US Holdings LLC is recalling 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.
What is being recalled
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.
Why
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0595-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | June 4, 2026 |
| Reported | June 17, 2026 |
| Company | Haleon US Holdings LLC |
| Company location | Warren, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 35,883 boxes/carton |
More recalls from Haleon US Holdings LLC · all drug recalls · recalls from June 2026