FDA Issues Highest Risk Level for Recalled Over-the-Counter Drug

A notice published by the Food and Drug Administration (FDA) labeled an ongoing recall of Gas-X as the most serious and urgent risk level due to contamination of the product.

In a notice published last week, the FDA said on June 17 it classified the recall of several lots of Gas-X, an over-the-counter anti-bloating medication, as Class I, or the most serious.

The reason for the Gas-X recall and classification, it said, is due to a “chemical contamination” caused by “diluted propylene glycol-based coolant from a machine leakage during the packaging process.”

“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,” a news release about the recall issued earlier this month said.

Propylene glycol is a liquid used by several different industries, including as a solvent in food colorings, flavorings, and pharmaceuticals, although it is also used to make resins, brake fluids, antifreeze, and other industrial products, health officials say. Overexposure to the liquid can cause vomiting or nausea, dizziness, headaches, or lightheadedness.

The manufacturer, Haleon, said that it has not received any reports of adverse events or health problems related to this recall, but it stressed at the time that “consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.”

According to the FDA’s website, a Class I recall is “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.”

Lots Under Recall

The FDA report said the recall applies to batches of Gas-X that include these details on the product label:

• Gas-X Extra Strength; simethicone in 125-milligram doses; 120-count SoftGels UPC 3 00674 35041 9; lot numbers of TL8K, YH9X, YH9Y; and a Nov. 30, 2028 expiration date. The products were distributed between April 13, 2026, and May 5, 2026.

• Gas-X Extra Strength; simethicone in 125-milligram doses; 72-count SoftGels; UPC 3 00439 00572 1; a lot number of X78N; and a Nov. 30, 2028 expiration date. The products were distributed between May 5, 2026, and May 14, 2026.

The recall is ongoing and nationwide, the FDA notice said. It added that 35,883 boxes or cartons were impacted.

No other lots of the Gas-X Extra Strength medication were affected, Haleon said in its news release. The company added that its Gas-X Ultra, Gas-X Maximum, and Gas-X Ultimate products were not impacted by the recall.

Separately, 285,330 blister cards of Gas-X were placed under recall because of “incomplete inactive ingredient information on the carton labeling,” the FDA said in May.