FDAClass I · Drug · Recalled June 17, 2026

Gas-X Extra Strength recall — Haleon US Holdings LLC

Hazard: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0595-2026
Brand: Haleon US Holdings
Classification: Class I
Units affected: 35,883 boxes/carton
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

Affected products

Gas-X Extra Strength

Companies & origin

Recalling firm location: Warren, NJ, United States
Firm address: 184 Liberty Corner Rd Ste 200, N/A, 07059-6870

Identifying details (verbatim from the notice)

Product codes / lots: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Distribution: Nationwide within the United States
Firm notified the public via: Press Release
FDA event ID: 99125
Recall initiated: June 4, 2026
FDA classified: June 17, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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