Haleon recalls Gas-X Simethicone 125mg Softgels due to incomplete labeling
Haleon recalls Gas-X Simethicone 125mg 120-count softgels for incomplete inactive ingredient labeling on carton. Consumers should check product details and contact Haleon for more information.
Lower-risk recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Contact the company
What happened, in plain English
Haleon is recalling Gas-X Simethicone 125mg 120-count softgels because the carton labeling lacks complete inactive ingredient information. This labeling issue does not pose a safety risk but may affect product transparency. Read more at govinfonow.com/recall/31314-haleon-recalls-gas-x-simethicone-125mg-softgels-due-to-incomplete.
Source Summary by GovInfoNow · govinfonow.com/recall/31314-haleon-recalls-gas-x-simethicone-125mg-softgels-due-to-incomplete · Updated August 17, 2026 · FDA enforcement record: FDA #D-0542-2026
Cite this page
“Haleon recalls Gas-X Simethicone 125mg Softgels due to incomplete labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31314-haleon-recalls-gas-x-simethicone-125mg-softgels-due-to-incomplete. Based on FDA recall #D-0542-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0542-2026%22&limit=1).
Why it’s dangerous
The product's carton labeling does not include all inactive ingredients as required. This labeling omission does not cause physical harm but may lead to confusion about the product's composition.
Who’s affected
Owners of Gas-X Simethicone 125mg 120-count softgels with the specified UPC code and lot numbers are affected. People using the product for gas relief may be at risk of incomplete ingredient information.
How to tell if you have this one
Check for the UPC code 3 00674 35041 9 on the carton. The product includes lot numbers KB5Y, MP4B, or SS4F with expiration dates up to April 2028.
- Brand
Haleon- Product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9- Category
Drug
What to do — step by step
Check Product Details
Verify the UPC code and lot numbers on the carton to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0542-2026 (May 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0542-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.