Gas-X Extra Strength Recall Due to Chemical Contamination
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Haleon US Holdings LLC is recalling Gas-X Extra Strength softgels nationwide due to chemical contamination from machine leakage during packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Haleon US Holdings LLC initiated a voluntary recall of Gas-X Extra Strength due to Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. The recall is classified as Class I by the FDA and affects products distributed nationwide within the United States.
Which Products Are Affected
- Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS
- a) 120 SoftGels (UPC 3 00674 35041 9)
- b) 72 SoftGels (UPC 3 00439 00572 1)
- Distributed by: Haleon, Warren, NJ 07059
- Lots: a) TL8K, YH9X, YH9Y (Exp. Date 30Nov2028); b) X78N (Exp. Date 30Nov2028)
- Quantity: 35,883 boxes/carton
- Recall number: D-0595-2026
- Event ID: 99125
What You Should Do
Consumers should verify lot numbers on purchased packages against the affected lots listed above.
Why This Matters
This Class I recall involves nationwide distribution of 35,883 boxes potentially contaminated during manufacturing, posing a serious health risk.
Source
FDA recall number D-0595-2026 (event ID 99125).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,069 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.