Overview
A drug recall is a voluntary or FDA-requested action taken by a manufacturer to remove a medication from the market, or to correct it, because it does not meet safety, quality, or labeling standards. Recalls are one of the primary tools the FDA and drug manufacturers use to protect patients once a problem is discovered after a product has already reached pharmacies and consumers.
This specific drug recall involving Gas-X is classified as Class II, and was reported on May 27, 2026 by Haleon US Holdings LLC.
The sections below explain, in plain language, what is known about this drug recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.
What Happened
Haleon US Holdings LLC initiated action on Gas-X on May 27, 2026 after identifying a labeling or packaging error. The action affects specific lots or units of this medication rather than every unit ever produced, so not every package on the market is necessarily involved.
The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.
Affected Products
The product identified in this notice is Gas-X, manufactured or distributed by Haleon US Holdings LLC.
FDA records describe the affected product as: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.; a reported quantity of 285,330 blister cards; distribution reported as U.S. Nationwide.; origin or reporting location of Warren, NJ, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.
Reason
Based on FDA records, this notice was driven by a labeling or packaging error. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.
According to the FDA's Drug Enforcement Report database, the stated reason was: "Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling."
The underlying cause of an issue like this can range from a manufacturing deviation at a single facility to a broader design or formulation problem. The official FDA record linked at the end of this article is the authoritative source for the full technical explanation.