FDA recall, , Moderate risk
Gas-X Simethicone Antigas Softgels
Gas-X antigas softgels have incomplete inactive ingredient information on the carton labeling.
Summary by Recall Canary from the FDA notice
What happened
Haleon US Holdings LLC, of Warren, New Jersey, recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, distributed by Haleon, Warren, NJ 07059, because the carton labeling has incomplete inactive ingredient information. The recall began on May 11, 2026, and was added to the FDA's Enforcement Report on May 19, 2026, with the agency classifying it that same day. The product was distributed nationwide in the U.S.
The recall covers 285,330 blister cards. The product was listed in the FDA's weekly enforcement report on May 27, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the UPC and lot code listed under your product.
A UPC is the number printed under a barcode.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels
- UPC
- 3 00674 35041 9
- Lot code
- KB5Y
- MP4B
- SS4F
Recall details
- Company began the recall
- Sold in
U.S. Nationwide.
- Company
- Haleon US Holdings LLCWarren, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98910
- Recall number
- D-0542-2026
- Quantity recalled
- 285,330 blister cards
All recalls from Haleon US Holdings LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
