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Haleon US: multiple softgels
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DRUG RECALLCRITICAL

Haleon US: multiple softgels

Haleon recalls Gas-X Extra Strength softgels (120 & 72 ct) over possible coolant contamination.

What to do

Stop using the recalled Gas-X Extra Strength softgels and return them to the place of purchase for a refund. Contact Haleon for further instructions.

Recalled
Updated
Recall No.
D-0595-2026
Agency
FDA
Firm
Haleon US Holdings LLC
Recall ID
99125
Status
ONGOING

Recall at a glance

Quantity recalled
35,883 boxes/carton

Why it was recalled

Haleon is recalling Gas-X Extra Strength SIMETHICONE 125 mg/ANTIGAS softgels in 120-count and 72-count packages due to potential chemical contamination from coolant that leaked from a machine during packaging. The affected products were sold nationwide.

Is mine affected?

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

Gas-X Extra Strength Softgels

ProductLot codeBest-byUPCDistribution
(120 ct.)TL8K, YH9X, YH9Y30 Nov 2028 30 Nov 2028 30 Nov 202830067435041913 Apr 2026 - 05 May 2026
(72 ct.)X78N30 Nov 202830043900572105 May 2026 - 14 May 2026

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

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Editorial summary by Recall Canary · summary updated 2026-08-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification