Gas-X recall (Haleon US Holdings LLC)
DrugClass IIOngoing
Summary: Haleon US Holdings LLC is recalling Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
What is being recalled
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Why
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide.
How to tell if yours is affected
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0542-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 11, 2026 |
| Reported | May 27, 2026 |
| Company | Haleon US Holdings LLC |
| Company location | Warren, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 285,330 blister cards |
More recalls from Haleon US Holdings LLC · all drug recalls · recalls from May 2026