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FDA Recalls Popular OTC Drug Over Contamination Risk

FDA Recalls Popular OTC Drug Over Contamination Risk
FDA Recalls Popular OTC Drug Over Contamination Risk

Before reaching for that bottle of Gas-X to settle an upset stomach, check the label first. Multiple lots of Gas-X Extra Strength Softgels have been recalled by Haleon, the health and wellness company behind the brand, due to contamination concerns. The Food and Drug Administration (FDA) announced the recall after discovering that the pills may have been tainted with a diluted propylene glycol-based coolant that leaked from a machine during packaging.

Ingesting softgels contaminated with this coolant could lead to nausea, vomiting, abdominal pain, and diarrhea, according to the agency. As of the recall announcement, no adverse events had been reported. The recall only applies to specific lots of the product, which are easily identified by a distinctive green band on the packaging β€” distinguishing them from other Gas-X items like Gas-X Ultra, Gas-X Maximum, and Gas-X Ultimate.

How to check if your medication is affected

If you’re worried about your supply, the lot number is printed on the back of the internal blister pack and on the bottom of the box. The recalled lots include:

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  • Gas-X Extra Strength Softgels, 120-count: UPC 300674350419; Lots TL8K, YH9X, and YH9Y; Expiration date November 30, 2028; Distributed between April 13, 2026 and May 5, 2026
  • Gas-X Extra Strength Softgels, 72-count: UPC 300439005721; Lot X78N; Expiration date November 30, 2028; Distributed between May 4, 2026 and May 14, 2026

The agency says Haleon is notifying its distributors and customers and is arranging for the return of all recalled products. The company also reports that the root cause of the contamination has been identified and repaired, and steps have been taken to prevent it from happening again.

It’s not clear how widely the contaminated lots were distributed, or how many bottles may still be on store shelves. Consumer safety advocates have raised questions about whether the firm’s internal checks caught the problem early enough, but the recall itself suggests a fairly quick response once the contamination was discovered.

What to do if you have a recalled bottle

If your product matches one of the lots listed above, stop taking it right away. To return the product and get a refund, contact Haleon’s consumer relations team by email at [email protected] or by phone at 1-800-245-1040.

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If you or someone you know experiences a related adverse reaction, you should contact a doctor first. After that, report the reaction to Haleon’s consumer relations team. The health agency also accepts reports through its online MedWatch Adverse Event Reporting program, or by mail or fax.

This isn’t the first time an over-the-counter medication has been recalled over contamination from manufacturing equipment.

It does serve as a reminder that even well-known brands can have production issues, and that checking lot numbers β€” as tedious as it sounds β€” really does matter.

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The affected softgels expire in November 2028.

People often stock up on these things and forget about them.

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