Class I U.S. Food and Drug Administration

Gas-X Gass-X Extra Strength Softgels 120 and 72ct recall: Potential chemical contamination

Recall published 5 months ago

Potential chemical contamination

Gas-X Prescription & OTC drugs — recalled prescription & otc drugsGas-X Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Gas-X Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Gas-X Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain and diarrhea.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0595-2026
Published
June 4, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Gas-X
Product type
Prescription & OTC drugs
Units affected
35,883 boxes/carton
Distribution
Nationwide
Lot / code info
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
UPC codes
300674350419, 300439005721

Products covered by this recall

Gass-X Extra Strength Softgels 120 and 72ct

What the company announced

WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) 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 lots are being recalled due to potential contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain and diarrhea.

To date, Haleon has not received any reports of adverse events related to this recall.

Gas-X Extra Strength Softgels are indicated to quickly break up gas bubbles in the digestive tract and relieve pressure, bloating, and discomfort. Gas-X Extra Strength Softgels are uniquely identified as a green capsule and found in packaging with a green band. Only the lots in the table below are impacted. No other lots of Gas-X Extra Strength, Gas-X Ultra, Gas-X Maximum and Gas-X Ultimate are impacted by this recall.

  • Product: Gas-X Extra Strength Softgels (120 ct.) · UPC: 300674350419 · Lot Number: TL8K YH9X YH9Y · Expiry Date: 30 Nov 2028 30 Nov 2028 30 Nov 2028 · Dates of Distribution: 13 Apr 2026 - 05 May 2026
  • Product: Gas-X Extra Strength Softgels (72 ct.) · UPC: 300439005721 · Lot Number: X78N · Expiry Date: 30 Nov 2028 · Dates of Distribution: 05 May 2026 - 14 May 2026

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Haleon is notifying its distributors and customers by letter, email, and phone notification, and is arranging for the return of all recalled products.

Consumers who have purchased Gas-X Extra Strength Softgels on or after April 13, 2026, should review the lot number. If the lot number matches those impacted by this recall, stop taking the product immediately and contact the Haleon Consumer Relations team at +1-800-245-1040 (Monday through Friday 8 a.m. to 6 p.m. ET), or via [email protected] or https://haleon.help/en-us/contact-form to arrange for return of the product and request reimbursement.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. 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 [email protected] or https://haleon.help/en-us/contact-form .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm .

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Consumer safety and product quality are our utmost priorities at Haleon. The root cause of the contamination has been identified and repaired. Corrective and preventative actions have been implemented to prevent future recurrence.

About Haleon

Haleon (LSE/NYSE: HLN) is a globally leading consumer company that is solely focused on better everyday health. Haleon's product portfolio spans three major categories - Oral Health, Over-the-Counter (OTC), and Wellness. Its long-standing brands - such as Advil, Centrum, Parodontax, Sensodyne, Theraflu, and TUMS - are built on trusted science, innovation and deep human understanding. For more information on Haleon and its brands, please visit www.haleon.com or contact [email protected] .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 300674350419
  • 300439005721

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • TL8K YH9X YH9Y
  • X78N

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 30 Nov 2028
  • 30Nov2028

Package size

Match the net weight or the piece count on the front of the pack.

  • 72 ct
  • 125 mg
  • 120 ct

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Gas-X — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Haleon — Consumers: Haleon Consumer Relations, 1-800-245-1040, [email protected] — Media: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Gas-X prescription & otc drugs recalled?

Potential chemical contamination There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain and diarrhea.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 300674350419, 300439005721; lot code TL8K YH9X YH9Y, X78N; best-by date 30 Nov 2028 or 30Nov2028. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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