FDAClass II · Drug · Recalled May 27, 2026

Gas-X recall — Haleon US Holdings LLC

Hazard: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0542-2026
Brand: Haleon US Holdings
Classification: Class II
Units affected: 285,330 blister cards
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Affected products

Gas-X

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Distribution: U.S. Nationwide.
Firm notified the public via: Letter
FDA event ID: 98910
Recall initiated: May 11, 2026
FDA classified: May 19, 2026
FDA report date: May 27, 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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