Serious riskFDA DrugClass I

Gas-X Extra Strength SoftGels recalled for coolant contamination

Gas-X Extra Strength softgels were contaminated with a diluted propylene glycol-based coolant during packaging due to a machine leak. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Haleon recalls

Update since first reported

  • Jun 17, 2026FDA classified this recall Class I, its most serious level

What to do

  1. Check if you own Gas-X Extra Strength in 120-count or 72-count packages with lot numbers TL8K, YH9X, YH9Y, or X78N (expiration date November 30, 2028).
  2. Do not use the affected product.
  3. Contact Haleon or the FDA for instructions on how to return or dispose of the product.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
UPC codes
  • 300674350419
  • 300439005721
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
35,883 boxes/carton
Illnesses reported
None reported
Manufactured in
184 Liberty Corner Rd Ste 200, N/A, Warren, NJ, United States
Classification
Class I
Recall number
D-0595-2026

In the FDA's words

Description
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028. Distribution: Nationwide within the United States Affected quantity: 35,883 boxes/carton
Hazard
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Also reported as

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