Skip to content
Back to recalls
Drug FDA Class II Ongoing Mislabeling

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Haleon US Holdings LLC Published May 27, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Haleon US Holdings LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Affected products (1)

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

285,330 blister cards

Lot codes: KB5Y
Code info: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 11, 2026
  2. Published
    May 27, 2026
Recall number
D-0542-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.