Gas-X Softgels are being recalled after the discovery that a machine coolant leaked into the packaging process, potentially contaminating four lots of 125 mg Gas-X Extra Strength Softgels in 120-count and 72-count bottles, the Food and Drug Administration said. Haleon, the maker of Gas-X, issued a voluntary recall after identifying that a diluted propylene glycol-based coolant could have entered the capsules during packaging. The affected products include 120-count bottles with lot numbers TL8K, YH9X and YH9Y and 72-count bottles with lot number X78N. These lots were distributed on or around April 13 and carry an expiration date of November 30, 2028. The recall spans both 120-count and 72-count packaging, and the recall boxes feature green, blue and gray banding that identifies the Gas-X Extra Strength Softgels.
The company disclosed that ingestion of the contaminated softgels could lead to adverse events such as nausea, vomiting, abdominal pain and diarrhea. Haleon noted that as of the report, it had not received any adverse-event reports linked to the recall. Consumers who purchased products matching the affected lot numbers were urged to stop taking the pills and contact Haleon for return and reimbursement. Haleon said it has notified distributors and customers by letter, email and phone and is arranging the return of all recalled products. The company described consumer safety and product quality as its utmost priorities and said corrective and preventative actions have been implemented to prevent future recurrence. Haleon is also the maker of other well-known medicines, including Advil, Theraflu and Tums.
The recall follows an earlier announcement that a machine leak during packaging caused potential coolant contamination, triggering the four four-lot recall across multiple package sizes. Authorities and Haleon have stated that the risk to the general public remains limited given the specific lots affected, but they emphasized the importance of stopping use of the recalled products immediately and returning them through proper channels. The recall is part of a broader public-safety effort to ensure that drug and over-the-counter products maintain high quality standards through strict manufacturing controls.
This event underscores ongoing vigilance by regulators and manufacturers in the consumer health arena as globalization and complex supply chains complicate quality assurance. Haleon has pledged to continue cooperating with regulators and to strengthen measures to prevent any recurrence, including enhanced screening and packaging-process controls. The FDA reiterates that consumers should check packaging and lot codes to confirm whether their Gas-X products are affected and seek guidance from healthcare providers if there are any concerns about symptoms after intake.
