Haleon recalls Gas-X Extra Strength softgels in a Class I coolant-leak action
The FDA logged a Class I recall of 35,883 boxes of the simethicone antigas product on 17 June, after softgels were contaminated with a propylene glycol-based coolant that leaked from packaging machinery.
Haleon is recalling a widely sold over-the-counter product, Gas-X Extra Strength softgels, after the pills were contaminated during manufacture. The Food and Drug Administration logged the action in its enforcement database on 17 June 2026 and classified it as Class I, the agency's most serious recall tier, used when exposure to a defective product could cause serious harm [s1]. The cause given in the record is a chemical contamination: a diluted propylene glycol-based coolant that leaked from a machine during the packaging process [s1].
What is affected
The recall covers Gas-X Extra Strength, containing simethicone 125 mg, distributed by Haleon of Warren, New Jersey [s1]. Two package sizes are named: 120-softgel bottles (UPC 3 00674 35041 9) and 72-softgel bottles (UPC 3 00439 00572 1) [s1]. The enforcement record lists 35,883 boxes in the affected quantity, distributed nationwide across the United States [s1]. The affected lots are TL8K, YH9X and YH9Y in the larger size and X78N in the smaller, all with an expiry date of 30 November 2028 [s1]. Haleon began the recall on 4 June 2026, announced it by press release, and the action is recorded as voluntary and firm-initiated [s1].
What the product is
Simethicone is one of the most familiar over-the-counter remedies on a pharmacy shelf. Its Drug Facts label lists its purpose as an antigas agent and its use as relief of the pressure, bloating and fullness commonly referred to as gas [s2]. It is not absorbed into the bloodstream in any meaningful amount and works mechanically in the gut, which is part of why it is generally regarded as low-risk in ordinary use. That ordinary safety profile is exactly what a contamination recall sets aside: the hazard here is not the simethicone but what leaked into the product alongside it.
Why a coolant leak triggers a Class I recall
Propylene glycol itself is a common, generally low-toxicity ingredient found in many foods and medicines. The problem flagged by the recall is not that substance in isolation but an industrial coolant based on it, introduced into a finished oral drug by a machine leak — an unintended, uncharacterised contaminant in a product meant to be swallowed [s1]. A coolant is a mixture formulated for machinery, not for consumption, and its full composition is not something a consumer can assess from the bottle.
The Class I label reflects the potential seriousness of ingesting such a contaminant rather than a tally of reported illnesses. As with any enforcement report, the record documents the defect, the scope and the classification; it does not state that anyone was harmed [s1].
The route of contamination matters for how far it may have spread. A machine leak during packaging can affect product intermittently across a run, which is one reason recalls of this kind are defined by lot codes rather than by a single bottle. Here the agency's record ties the defect to four specific lots sharing a 30 November 2028 expiry, packaged in the 120- and 72-count sizes, and distributed nationwide [s1].
How to read it
The practical takeaway is narrow and specific. This is a lot-limited recall of four named lots of one product, all sharing a single expiry date, not a withdrawal of simethicone as a class [s1]. Anyone holding Gas-X Extra Strength can check the lot code and UPC on the package against the agency's record; product outside those lots is not part of this action. Because the recall was announced by press release and the product is a mass-market consumer item, the burden of checking falls on households as much as on retailers [s1].
It is also a reminder that manufacturing defects, not the active ingredient, drive a large share of drug recalls. A familiar, low-risk medicine can still be recalled at the highest severity level when something foreign enters it on the production line.
This article describes an FDA enforcement action and is not medical advice. Anyone who has taken a recalled lot and feels unwell should contact a clinician or a poison-control service; questions about a specific product can be checked against the agency's enforcement record by lot number and UPC.
Sources
- FDA Enforcement Report D-0595-2026: Gas-X Extra Strength (simethicone 125 mg) softgels — U.S. Food and Drug Administration, report date 17 June 2026
- Gas-X (simethicone) — over-the-counter Drug Facts label — U.S. Food and Drug Administration, label effective 20 May 2025
Sources
- FDA Enforcement Report D-0595-2026: Gas-X Extra Strength (simethicone 125 mg) softgels — U.S. Food and Drug Administration (openFDA drug/enforcement API) , June 17, 2026
- Gas-X (simethicone) — over-the-counter Drug Facts label — U.S. Food and Drug Administration (openFDA drug/label API) , May 20, 2025
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