INDIANA — The Food and Drug Administration (FDA) has escalated a nationwide recall affecting hundreds of thousands of packages of Gas-X softgels due to a packaging error that left critical ingredient information off the boxes.
The enforcement action targets Gas-X Simethicone 125 mg Antigas softgels distributed across the United States by Haleon US Holdings LLC. According to newly updated tracking data from the FDA, the recall covers 285,330 individual blister cards.
The voluntary recall was quietly initiated by Haleon on May 11, 2026, after the manufacturer discovered that the outer carton labeling failed to include a complete list of the product’s inactive ingredients. On May 19, the FDA officially designated the situation as a Class II recall.
The FDA applies a Class II classification to products that present a moderate health risk. This designation means exposure to the recalled medication is unlikely to cause permanent or life-threatening injuries, but it could cause temporary or medically reversible adverse health effects.
In this case, the risk is not tied to the active, gas-relieving medication itself. Instead, the danger lies in the incomplete inactive ingredients list. If an individual has a severe allergy or intolerance to a hidden binder, preservative, or coloring agent used in the softgel shell, consuming the product without a proper label could trigger an unexpected allergic reaction.
To date, there have been no reported illnesses or adverse consumer reactions linked to the impacted lots.
Consumers are urged to check their medicine cabinets and emergency kits for the affected over-the-counter packages. The specific items pulled from retail shelves can be identified using the following manufacturing details:
| Product Name | Package Size | UPC Barcode |
| Gas-X, Simethicone 125 mg / Antigas | 120-Count SoftGels | 3 00674 35041 9 |
The recall is restricted to three specific manufacturing lot numbers with accompanying expiration dates:
- Lot Code:
KB5Y(Expires: 04/2028) - Lot Code:
MP4B(Expires: 05/2028) - Lot Code:
SS4F(Expires: 09/2028)
Guidance for Consumers
While the federal government has not issued an outright ban on the underlying medicine, safety experts recommend that consumers immediately stop using the softgels if their package matches the recalled lot numbers.
If you own a box from the affected batch, you should dispose of the medication safely or return it to the point of purchase—such as Sam’s Club or other national retailers—for a full refund. Consumers seeking more details regarding the mislabeling or return logistics can contact Haleon’s customer care line or review the ongoing active case log on the FDA’s enforcement directory.
