Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS
Recalled by Haleon US Holdings LLC
Drug recall
Haleon US Holdings LLC
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
Haleon US Holdings LLC has recalled Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 17, 2026 and was initiated on June 4, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, with approximately 35,883 boxes/carton affected. The company behind the recall is Haleon US Holdings LLC, based in Warren, NJ. The FDA describes the product as: “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 was Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS recalled?
According to the FDA, the stated reason for the recall is: “Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.”
What should you do?
If you think you may have bought Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, compare it against the product description and identifying codes (Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Haleon US Holdings LLC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- June 17, 2026
- Recall started
- June 4, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS recalled?+
According to the FDA: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin…
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0595-2026. Information last synced from the FDA on July 5, 2026.