The FDA classified an ongoing recall of several Gas-X Extra Strength SoftGel lots as Class I after diluted propylene glycol-based coolant may have contaminated products during packaging.
By yourNEWS Media Newsroom
The Food and Drug Administration has assigned its highest risk level to an ongoing recall of several lots of Gas-X Extra Strength SoftGels after the over-the-counter anti-bloating medication may have been contaminated during the packaging process.
The FDA said in a notice published last week that it classified the recall as Class I on June 17. A Class I recall is the agency’s most serious designation and applies when there is a reasonable probability that use of or exposure to a product will cause serious health consequences or death.
The recalled Gas-X products may have been contaminated by “diluted propylene glycol-based coolant from a machine leakage during the packaging process,” according to the FDA.
A recall notice issued earlier this month said people who ingest contaminated SoftGels could experience symptoms including nausea, vomiting, abdominal pain and diarrhea.
“There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain, and diarrhea,” the release stated.
Propylene glycol is a liquid used in several industries. Health officials say it is used as a solvent in some food colorings, flavorings and pharmaceuticals, but it is also used in industrial products including resins, brake fluids and antifreeze.
Overexposure to propylene glycol can cause nausea, vomiting, dizziness, headaches or lightheadedness.
Haleon, the manufacturer, said it had not received reports of adverse events or health problems connected to the recall. The company advised consumers to contact a physician or healthcare provider if they experienced any problems that may be related to taking or using the recalled product.
The nationwide recall remains ongoing and affects 35,883 boxes or cartons, according to the FDA notice.
The recalled products include Gas-X Extra Strength SoftGels containing 125 milligrams of simethicone in 120-count packages. The affected products carry UPC 3 00674 35041 9, lot numbers TL8K, YH9X and YH9Y, and an expiration date of Nov. 30, 2028. Those products were distributed from April 13, 2026, through May 5, 2026.
The recall also includes Gas-X Extra Strength SoftGels containing 125 milligrams of simethicone in 72-count packages. Those products carry UPC 3 00439 00572 1, lot number X78N, and an expiration date of Nov. 30, 2028. They were distributed from May 5, 2026, through May 14, 2026.
Haleon said no other lots of Gas-X Extra Strength were affected. The company also said Gas-X Ultra, Gas-X Maximum and Gas-X Ultimate products were not included in the recall.
The contamination-related recall is separate from another Gas-X recall identified by the FDA in May. In that case, 285,330 blister cards were recalled because of “incomplete inactive ingredient information on the carton labeling.”
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