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Unrated Drug recall · FDA · Published June 4, 2026

Haleon Gas-X Extra Strength Softgels Recall: Chemical Contamination Risk

Haleon recalls Gas-X Extra Strength softgels due to potential chemical contamination from machine leakage during packaging. Affected lots expire Nov 2028. Consumers should check UPCs and lot numbers.

🇺🇸 FDA recall #D-0595-2026DrugHaleon ›
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Recalling firmHaleon US Holdings LLC184 Liberty Corner Rd Ste 200 · Warren, NJ 07059-6870
✎ GovInfoNow plain-language explainer

Haleon is recalling Gas-X Extra Strength softgels that may contain chemical contaminants from machine leaks during production. This could pose a risk of harm if ingested, though the exact danger level isn't specified in the recall notice. Read more at govinfonow.com/recall/31218-haleon-gas-x-extra-strength-softgels-recall-chemical-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31218-haleon-gas-x-extra-strength-softgels-recall-chemical-contamination-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0595-2026

Cite this page

“Haleon Gas-X Extra Strength Softgels Recall: Chemical Contamination Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31218-haleon-gas-x-extra-strength-softgels-recall-chemical-contamination-risk. Based on FDA recall #D-0595-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0595-2026%22&limit=1).

Haleon US Holdings LLC voluntarily recalled Gas-X Extra Strength softgels on June 4, 2026, due to chemical contamination with diluted propylene glycol-based coolant. The Food and Drug Administration announced the Class I recall.

How to tell if you have it

  • Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, 120 SoftGels (UPC 3 00674 35041 9)
  • Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, 72 SoftGels (UPC 3 00439 00572 1)
  • Lots TL8K, YH9X, YH9Y, Exp. Date 30Nov2028
  • Lot X78N, Exp. Date 30Nov2028

The hazard

The product is contaminated with a diluted propylene glycol-based coolant from machine leakage during the packaging process.

Context

GovInfoNow's records show Haleon US Holdings LLC has issued four other recalls since December 26, 2023. Recent similar recalls include the Gas-X Simethicone 125mg Softgels recall on May 11, 2026, and the Parodontax Mouthwash Recall on December 26, 2025. Other recent recalls of similar products include the Keystone DHP Topical Anesthetic Gel Recall (May 21, 2026), the Keystone Pearson Topical Anesthetic Gel Recall (May 21, 2026), and the Keystone Dental City Topical Anesthetic Gel Recall (May 21, 2026).

How to tell if you have this one

Check for the UPC numbers: 3 00674 35041 9 (120 softgels) or 3 00439 00572 1 (72 softgels). Products with expiration dates of November 30, 2028, are affected.

  • Brand
    Haleon
  • Product
    Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the UPC numbers and expiration dates listed in the recall notice to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 13 days after the firm started it.

1. Firm started the recall: Jun 4, 202612. FDA classified it Class I: Jun 17, 202623. Published in FDA’s Enforcement Report: Jun 17, 202632026
  1. Firm started the recall
  2. FDA classified it Class I
  3. 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-0595-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0595-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA