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orywireHaleon recalled four lots of Gas-X Extra Strength Softgels 125 mg after possible coolant contamination during packaging. Consumers should check UPCs and lot numbers TL8K, YH9X, YH9Y and X78N and stop using affected packages.
Haleon is recalling four lots of Gas-X Extra Strength Softgels because they may have been contaminated during packaging with a diluted propylene glycol-based coolant. Consumers who bought the 72-count or 120-count Extra Strength softgels on or after April 13 should check the lot number and stop using the product if it matches the recall.
The recall covers only Gas-X Extra Strength Softgels 125 mg in 120-count and 72-count packages. Haleon said the softgels are green capsules in packaging with a green band, but the lot number is the detail consumers need to check.
The notice says no other lots of Gas-X Extra Strength, Gas-X Ultra, Gas-X Maximum or Gas-X Ultimate are included in this recall.
The FDA posted Haleon’s company announcement June 4 as part of the agency’s recalls, market withdrawals and safety alerts page. The agency says it posts company announcements as a public service and does not endorse the product or the company.
Haleon described the action as a voluntary nationwide consumer-level recall conducted with FDA knowledge. The recall applies to four lots distributed on or about April 13 to the consumer level.
Haleon said the affected lots may have been exposed to a diluted propylene glycol-based coolant because of machine leakage during the packaging process.
The company said ingestion of contaminated softgels may result in adverse events such as nausea, vomiting, abdominal pain and diarrhea. Haleon said it had not received reports of adverse events related to the recall as of the announcement.
Consumers who bought Gas-X Extra Strength Softgels on or after April 13 should compare the package lot number with the four recalled lots. Do not rely on the package size or product name alone; only the listed lots are included.
If the lot number matches, Haleon says consumers should stop taking the product immediately and contact Haleon Consumer Relations to arrange a return and request reimbursement.
Haleon Consumer Relations can be reached at 1-800-245-1040, Monday through Friday, 8 a.m. to 6 p.m. ET. Consumers can also email mystory.us@haleon.com or use Haleon’s online contact form.
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Anyone who has experienced a problem that may be related to taking or using the recalled product should contact a physician or other health care provider, Haleon said. Adverse reactions or quality problems can also be reported to FDA MedWatch.
Haleon said it is notifying distributors and customers by letter, email and phone and is arranging for the return of all recalled products.
The company also said the root cause of the contamination has been identified and repaired, and that corrective and preventive actions have been put in place to prevent a recurrence.
The FDA and Haleon notices checked did not list specific retailers or states where the affected lots were sold. The notices also did not name any additional Gas-X products outside the four lots listed above.
This article will be updated if FDA or Haleon posts additional lot numbers, retailer information, adverse-event reports or other recall details.
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