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Gas-X Simethicone 125 mg SoftGels
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DRUG RECALLMODERATE

Gas-X Simethicone 125 mg SoftGels

Haleon is recalling Gas-X Simethicone 125 mg SoftGels (120 count), UPC 3 00674 35041 9, due to incomplete inactive ingredient labeling.

What to do

Check your product packaging for UPC 3 00674 35041 9. If you have the affected product, stop using it and contact Haleon for further instructions or return it to the place of purchase.

Recalled
Listed
Updated
Recall No.
D-0542-2026
Agency
FDA
Firm
Haleon US Holdings LLC
Recall ID
98910
Status
ONGOING

Recall at a glance

Quantity recalled
285,330 blister cards

Why it was recalled

Haleon is recalling Gas-X Simethicone 125 mg Anti-Gas SoftGels (120 count) due to incomplete inactive ingredient information on the carton labeling. The affected product is identified by UPC 3 00674 35041 9.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Gas-X, Simethicone

Lot code
KB5Y, 2028
Strength
125 mg
NDC / UPC
UPC 3 00674 35041 9

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Haleon US Holdings LLC

All recalls from Haleon US Holdings LLC

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Editorial summary by Recall Canary · summary updated 2026-05-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification