FDA Announces Nationwide Gas-X Recall—Thousands of Boxes Affected

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digestive medication aisle

  • More than 285,000 blister cards of Gas-X, a medication for gas and bloating, have been recalled nationwide.
  • The recalled packages have a labeling error of incomplete inactive ingredient lists.
  • The recall has been given the second-highest risk level.

A nationwide recall has been initiated for thousands of boxes of Gas-X, according to the Food and Drug Administration (FDA). More than 285,000 blister cards (the packaging the pills are contained in) of the over-the-counter stomach medication were pulled from shelves on May 11 due to a labeling error: The inactive ingredient lists on the products are incomplete. On May 19, the FDA gave the recall the second-highest risk level, Class II, meaning the affected drugs are unlikely to cause permanent damage, but may cause temporary or reversible effects. 1

Identifying the Recalled Gas-X

The recalled Gas-X, distributed by Haleon US Holdings LLC, can be identified with the following information:

  • Product description: Gas-X, Simethicone 125 mg/Antigas
  • Size: 120 SoftGels
  • UPC: 3 00674 35041 9
  • Lot codes and expiration dates: lot: KB5Y, expires: 04/2028; lot: MP4B, expires: 05/2028; and lot: SS4F, expires: 09/2028
  • Affected quantity: 285,330 blister cards
gas-x package
Sam’s Club

What You Should Do

The FDA did not provide specific instructions, but as a Class II recall, the safest option is not to use the affected Gas-X. Throw it away or return it for a refund.

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