Why it was recalled
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Product 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.
Lot numbers, UPCs & expiration codes
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0595-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jun 4, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- 35,883 boxes/carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Haleon US Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0595-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99125
- Address
- 184 Liberty Corner Rd Ste 200
- Code information
- Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
- Postal code
- 07059-6870
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0595-2026
- Classification
- Class I
- Recalling firm
- Haleon US Holdings LLC
- Product quantity
- 35,883 boxes/carton
- Reason for recall
- Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 4, 2026
- Initial firm notification
- Press Release
- Center classification date
- Jun 17, 2026