The FDA has raised the recall of four lots of Gas-X Extra Strength Softgels to Class I after discovering potential contamination from a packaging machine coolant leak.
Consumers who purchased affected products after April 13, 2026, are urged to stop using them immediately and seek reimbursement.
No adverse events have been reported, but contaminated capsules could cause nausea, vomiting, abdominal pain, and diarrhea.
In early June, Haleon recalled four lots of Gas-X Extra Strength Softgels sold nationwide after discovering that some capsules may have been contaminated during the packaging process. Now, the U.S. Food and Drug Administration (FDA) has raised the recall’s threat level to Class I, the highest level.
The FDA has reported that another 35,000 boxes of the drugs have been added to the recall, citing: “Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.”
The original recall affects Gas-X Extra Strength Softgels 125 mg in 120-count and 72-count packages distributed to consumers beginning around April 13, 2026. Haleon said the affected products may have been exposed to a diluted propylene glycol-based coolant that leaked from a packaging machine.
The threat
According to the company, swallowing contaminated capsules could result in gastrointestinal symptoms including nausea, vomiting, abdominal pain, and diarrhea. However, Haleon said it has not received any reports of injuries or illnesses related to the recall.
The recall covers the following lots:
Gas-X Extra Strength Softgels, 120-count (UPC 300674350419), lot numbers TL8K, YH9X, and YH9Y
Gas-X Extra Strength Softgels, 72-count (UPC 300439005721), lot number X78N
All affected products have expiration dates of Nov. 30, 2028.
What to do
Haleon emphasized that the recall applies only to the specified lots of Gas-X Extra Strength Softgels. Other Gas-X products, including Gas-X Ultra, Gas-X Maximum, and Gas-X Ultimate, are not affected.
Consumers who purchased the recalled products should check the lot number on the package and stop using the medication if it matches one of the affected lots. The company is offering returns and reimbursement for recalled products.
Haleon said it has identified and repaired the source of the contamination and implemented corrective measures to prevent a recurrence. The recall is being conducted with the knowledge of the FDA.
Consumers who believe they experienced a reaction related to the recalled products should contact a healthcare provider and report the incident to Haleon or through the FDA's MedWatch adverse event reporting program.