Jun 4, 2026FDAactive

Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.

Haleon

Company announcement

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.

ProductUPCLot NumberExpiry DateDates of Distribution
Gas-X Extra Strength Softgels (120 ct.)300674350419TL8K YH9X YH9Y30 Nov 2028 30 Nov 2028 30 Nov 202813 Apr 2026 - 05 May 2026
Gas-X Extra Strength Softgels (72 ct.)300439005721X78N30 Nov 202805 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 mystory.us@haleon.com 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 mystory.us@haleon.com 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.

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.

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 USMediaRelations@haleon.com .

Product images

Official record — FDA enforcement

Official FDA enforcement data — classification, lot codes, and quantities — is published once FDA processes this recall, typically several weeks after the announcement. This page updates automatically when it arrives.

Source: U.S. Food & Drug AdministrationOriginal announcement ↗