A commonly used over-the-counter medication for stomach and gas ailments was recalled nationwide, according to a notice published on the Food and Drug Administration’s (FDA) database this week.
The notice said that 285,330 blister cards of Gas-X, which contains simethicone in 125-milligram doses, in 120-count soft gel packs, are under recall, according to the notice.
The recalling company, New Jersey-based Haleon US Holdings, said the reason for the recall is a labeling issue due to “incomplete inactive ingredient information on the carton labeling.” It did not provide any additional details.
Three lots of the medication are under recall: lot KB5Y has an expiration date of April 2024, lot MP4B has an expiration date of May 2028, and lot SS4F has an expiration date of September 2028.
The FDA, which included the alert in its recall database during the week of May 27, labeled the recall as Class II, which the FDA says is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Haleon—which also manufactures common over-the-counter medications and products such as Advil, Tums, Sensodyne, Excedrin, Benfiber, Centrum, and Flonase—initiated the recall, which is currently ongoing and nationwide, according to the notice. Haleon was established in 2022 as a corporate spin-off company of GSK.
While the recall notice did not say where the impacted lots of medication were sold, Gas-X is sold in stores across the United States and through major online retailers such as Amazon.
Gas-X contains the drug simethicone as its active ingredient. Simethicone is commonly used to treat gas symptoms such as feeling full, pressure, and bloating, according to the Cleveland Clinic. It’s also used during preparations for some medical procedures for the colon, such as colonoscopies.
The FDA mandates that all over-the-counter drugs be properly labeled for consumers so they can be easy to read, saying in a section on its website that labels must “have information listed in the same order; are arranged in a consistent style and contain easier to understand words.”
The health regulator also defines inactive ingredients as “substances such as binders, colors, or flavorings” and active ingredients as substances “in the product that cause the intended therapeutic effect,” according to the website.
Earlier this month, a research company released a report finding that U.S. product recalls increased 27 percent in the first three months of 2026, on a quarter-over-quarter basis. The figure rose to 492 million units that were recalled in the first quarter of this year, said Sedgwick’s quarterly Product Safety and Recall Index report.
