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Ongoing FDAEvent 99125 (4 months ago)

Gas-X Extra Strength Softgels

Gas-X Extra Strength Softgels may be contaminated with a diluted propylene glycol-based coolant, which could cause nausea, vomiting, abdominal pain.

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

11 photos

What to do

What happened

Haleon US Holdings LLC, of Warren, New Jersey, is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct., distributed on or about April 13, 2026, to the consumer level. The recall is due to potential contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. The product is packaged in 120 SoftGels and 72 SoftGels, and is distributed by Haleon, Warren, NJ 07059.

The recall was initiated by the company on June 4, 2026, and added to the FDA's Enforcement Report on June 8, 2026. The affected product was distributed nationwide within the United States.

Summary by Recall Canary from the FDA notice.

What to do

If a code on your package matches:

  1. Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this product.
  2. If the lot number matches those impacted by this recall, stop taking the product immediately.
  3. Contact the Haleon Consumer Relations team at +1-800-245-1040 (Monday through Friday 8 a.m. to 6 p.m. ET), or via mystory.us@haleon.com or https://haleon.help/en-us/contact-form to arrange for return of the product and request reimbursement.
  4. They should also report any adverse events to our Consumer Relations Team at +1-800-245-1040 (Monday through Friday 8 a.m. to 6 p.m. ET) or via mystory.us@haleon.com or https://haleon.help/en-us/contact-form.

Is yours affected?

Match the lot code, best-by date and UPC listed under your product.

  1. Gas-X Extra Strength Softgels (120 ct.)

    UPC
    • 300674350419
    Lot code
    • TL8K
    • YH9X
    • YH9Y
    Best-by
    30 Nov 2028 30 Nov 2028 30 Nov 2028
    Distribution
    13 Apr 2026 - 05 May 2026
  2. Gas-X Extra Strength Softgels (72 ct.)

    UPC
    • 300439005721
    Lot code
    • X78N
    Best-by
    30 Nov 2028
    Distribution
    05 May 2026 - 14 May 2026

Details

Company began the recall
Sold in

Nationwide within the United States

Event ID
99125
Recall No.
D-0595-2026
Company
Haleon US Holdings LLCWarren, New Jersey
Quantity recalled
35,883 boxes/carton
Recall type
Voluntary: Firm initiated
Customers told by
Press Release
  1. Company began the recall · Announced by the company

  2. Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. Classified by FDA · In FDA's weekly enforcement report

  5. Summary updated

All recalls from Haleon US Holdings LLC

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration